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USFDA Approvals for Indian Pharma Companies
New US FDA approvals (AP) and tentative approvals (TA) of original ANDA/NDA applications by listed Indian pharma companies, from Drugs@FDA via openFDA. Supplements (labelling, manufacturing changes) are not shown.
| Date | Company | Drug | Application | Type | Source |
|---|---|---|---|---|---|
| 27 Oct 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
TRANEXAMIC ACID | ANDA221213 | Approved | Drugs@FDA ↗ |
| 23 Oct 2026 | Dr. Reddy's Laboratories DR REDDYS |
TERIPARATIDE | ANDA214412 | Approved | Drugs@FDA ↗ |
| 20 Oct 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
BRIVARACETAM | ANDA221301 | Approved | Drugs@FDA ↗ |
| 19 Oct 2026 | Ajanta Pharma AJANTA PHARMA LTD |
TOFACITINIB CITRATE | ANDA219542 | Approved | Drugs@FDA ↗ |
| 19 Oct 2026 | Zydus Lifesciences ZYDUS PHARMS |
ROMIDEPSIN | ANDA220783 | Approved | Drugs@FDA ↗ |
| 19 Oct 2026 | Zydus Lifesciences ZYDUS PHARMS |
ESTRADIOL AND LEVONORGESTREL ESTRADIOL, LEVONORGESTREL |
ANDA220407 | Approved | Drugs@FDA ↗ |
| 16 Oct 2026 | Dr. Reddy's Laboratories DR REDDYS |
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE, PSEUDOEPHEDRINE SULFATE |
ANDA220432 | Approved | Drugs@FDA ↗ |
| 16 Oct 2026 | Cipla CIPLA |
CABOZANTINIB S-MALATE | ANDA217870 | Approved | Drugs@FDA ↗ |
| 16 Oct 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
UPADACITINIB | ANDA218866 | Approved | Drugs@FDA ↗ |
| 15 Oct 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES LIMITED |
ANDA218568 | Tentative | Drugs@FDA ↗ | |
| 13 Oct 2026 | Strides Pharma Science STRIDES PHARMA INTL |
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE |
ANDA208359 | Approved | Drugs@FDA ↗ |
| 06 Oct 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
SOLRIAMFETOL, SOLRIAMFETOL HYDROCHLORIDE | ANDA218725 | Approved | Drugs@FDA ↗ |
| 02 Oct 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
ANDA219349 | Tentative | Drugs@FDA ↗ | |
| 02 Oct 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
PERAMPANEL | ANDA220492 | Approved | Drugs@FDA ↗ |
| 30 Sep 2026 | Lupin LUPIN |
PHYTONADIONE | ANDA219175 | Approved | Drugs@FDA ↗ |
| 29 Sep 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
MUPIROCIN CALCIUM | ANDA218361 | Approved | Drugs@FDA ↗ |
| 29 Sep 2026 | Unichem Laboratories UNICHEM LABORATORIES LTD |
SOLRIAMFETOL | ANDA218761 | Tentative | Drugs@FDA ↗ |
| 25 Sep 2026 | Lupin LUPIN |
APIXABAN | NDA220446 | Tentative | Drugs@FDA ↗ |
| 25 Sep 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
METRONIDAZOLE | ANDA218485 | Approved | Drugs@FDA ↗ |
| 23 Sep 2026 | Zydus Lifesciences ZYDUS PHARMS |
MEXILETINE HYDROCHLORIDE | ANDA214598 | Approved | Drugs@FDA ↗ |
| 17 Sep 2026 | Cipla CIPLA |
CALCIUM GLUCONATE IN SODIUM CHLORIDE CALCIUM GLUCONATE |
ANDA217891 | Approved | Drugs@FDA ↗ |
| 17 Sep 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CYCLOSPORINE | ANDA219652 | Approved | Drugs@FDA ↗ |
| 15 Sep 2026 | Strides Pharma Science STRIDES PHARMA |
MILNACIPRAN HYDROCHLORIDE | ANDA207399 | Approved | Drugs@FDA ↗ |
| 15 Sep 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
TRETINOIN | ANDA218560 | Approved | Drugs@FDA ↗ |
| 14 Sep 2026 | Ajanta Pharma AJANTA PHARMA LTD |
HALOPERIDOL | ANDA218210 | Approved | Drugs@FDA ↗ |
| 14 Sep 2026 | Zydus Lifesciences ZYDUS PHARMS |
EPINEPHRINE | ANDA219832 | Approved | Drugs@FDA ↗ |
| 14 Sep 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
LETROZOLE | ANDA220438 | Approved | Drugs@FDA ↗ |
| 14 Sep 2026 | Aurobindo Pharma AUROLIFE PHARMA LLC |
BECLOMETHASONE DIPROPIONATE | ANDA214418 | Approved | Drugs@FDA ↗ |
| 10 Sep 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
ISOTRETINOIN | ANDA220336 | Approved | Drugs@FDA ↗ |
| 08 Sep 2026 | Glenmark Pharmaceuticals GLENMARK PHARMACEUTICALS LIMITED |
ANDA220307 | Tentative | Drugs@FDA ↗ | |
| 03 Sep 2026 | Lupin LUPIN |
MODAFINIL | ANDA208343 | Approved | Drugs@FDA ↗ |
| 02 Sep 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
SACUBITRIL AND VALSARTAN SACUBITRIL, VALSARTAN |
ANDA213631 | Approved | Drugs@FDA ↗ |
| 01 Sep 2026 | Zydus Lifesciences ZYDUS PHARMACEUTICALS (USA) INC. |
ANDA218652 | Tentative | Drugs@FDA ↗ | |
| 31 Aug 2026 | Cipla CIPLA |
POMALIDOMIDE | ANDA219718 | Approved | Drugs@FDA ↗ |
| 31 Aug 2026 | Dr. Reddy's Laboratories DR REDDYS |
POMALIDOMIDE | ANDA213234 | Approved | Drugs@FDA ↗ |
| 21 Aug 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
RIFABUTIN | ANDA219519 | Approved | Drugs@FDA ↗ |
| 20 Aug 2026 | Zydus Lifesciences ZYDUS PHARMS |
ASCORBIC ACID | ANDA220873 | Approved | Drugs@FDA ↗ |
| 19 Aug 2026 | Biocon BIOCON PHARMA |
NINTEDANIB ESYLATE | ANDA220118 | Approved | Drugs@FDA ↗ |
| 18 Aug 2026 | Dr. Reddy's Laboratories DR REDDYS LABS LTD |
CARBIDOPA AND LEVODOPA CARBIDOPA, LEVODOPA |
ANDA219231 | Tentative | Drugs@FDA ↗ |
| 18 Aug 2026 | Glenmark Pharmaceuticals GLENMARK SPECLT |
FLUTICASONE PROPIONATE | ANDA219232 | Approved | Drugs@FDA ↗ |
| 18 Aug 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES GLOBAL FZE |
ANDA219582 | Tentative | Drugs@FDA ↗ | |
| 17 Aug 2026 | Jubilant Pharmova JUBILANT GENERICS |
TADALAFIL | ANDA210592 | Approved | Drugs@FDA ↗ |
| 14 Aug 2026 | Lupin LUPIN |
PITOLISANT HYDROCHLORIDE | ANDA218846 | Approved | Drugs@FDA ↗ |
| 11 Aug 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
CANAGLIFLOZIN AND METFORMIN HYDROCHLORIDE CANAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA213900 | Tentative | Drugs@FDA ↗ |
| 11 Aug 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
TRIAMCINOLONE ACETONIDE | ANDA220110 | Approved | Drugs@FDA ↗ |
| 10 Aug 2026 | Aurobindo Pharma AUROBINDO PHARMA |
BRIVARACETAM | ANDA220288 | Approved | Drugs@FDA ↗ |
| 07 Aug 2026 | Lupin LUPIN |
SODIUM ZIRCONIUM CYCLOSILICATE | ANDA217549 | Approved | Drugs@FDA ↗ |
| 07 Aug 2026 | Aurobindo Pharma AUROBINDO PHARMA |
VANCOMYCIN HYDROCHLORIDE | ANDA218130 | Approved | Drugs@FDA ↗ |
| 06 Aug 2026 | Dr. Reddy's Laboratories DR. REDDY'S LABORATORIES LIMITED |
ANDA219312 | Tentative | Drugs@FDA ↗ | |
| 06 Aug 2026 | Dr. Reddy's Laboratories DR REDDYS |
LORATADINE AND PSEUDOEPHEDRINE SULFATE LORATADINE, PSEUDOEPHEDRINE SULFATE |
ANDA220448 | Approved | Drugs@FDA ↗ |
| 05 Aug 2026 | Aurobindo Pharma AUROBINDO PHARMA |
ESLICARBAZEPINE ACETATE | ANDA216481 | Approved | Drugs@FDA ↗ |
| 03 Aug 2026 | Biocon BIOCON PHARMA LIMITED |
CARBIDOPA AND LEVODOPA CARBIDOPA,LEVODOPA |
ANDA220119 | Tentative | Drugs@FDA ↗ |
| 03 Aug 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
INDOCYANINE GREEN | ANDA219139 | Approved | Drugs@FDA ↗ |
| 31 Jul 2026 | Mankind Pharma MANKIND PHARMA |
THIAMINE HYDROCHLORIDE | ANDA220513 | Approved | Drugs@FDA ↗ |
| 31 Jul 2026 | Dr. Reddy's Laboratories DR REDDYS LABS SA |
ZIMRIXBY RITUXIMAB-CDXX |
BLA761376 | Approved | Drugs@FDA ↗ |
| 30 Jul 2026 | Dr. Reddy's Laboratories DR REDDYS |
FEXOFENADINE HYDROCHLORIDE | ANDA220413 | Approved | Drugs@FDA ↗ |
| 28 Jul 2026 | Dr. Reddy's Laboratories DR REDDYS |
SUGAMMADEX SODIUM | ANDA214236 | Approved | Drugs@FDA ↗ |
| 28 Jul 2026 | Lupin LUPIN |
SUGAMMADEX SODIUM | ANDA214338 | Approved | Drugs@FDA ↗ |
| 28 Jul 2026 | Mankind Pharma MANKIND PHARMA |
SUGAMMADEX SODIUM | ANDA214230 | Approved | Drugs@FDA ↗ |
| 27 Jul 2026 | Lupin LUPIN |
DIAZEPAM | ANDA220365 | Approved | Drugs@FDA ↗ |
| 27 Jul 2026 | Cipla CIPLA |
FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE |
ANDA213087 | Approved | Drugs@FDA ↗ |
| 22 Jul 2026 | Zydus Lifesciences ZYDUS PHARMS |
EDARAVONE | ANDA218349 | Approved | Drugs@FDA ↗ |
| 22 Jul 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
ADAPALENE AND BENZOYL PEROXIDE ADAPALENE, BENZOYL PEROXIDE |
ANDA217384 | Approved | Drugs@FDA ↗ |
| 22 Jul 2026 | Biocon BIOCON PHARMA |
TOPIRAMATE | ANDA220943 | Approved | Drugs@FDA ↗ |
| 21 Jul 2026 | Zydus Lifesciences ZYDUS PHARMS |
FLUVOXAMINE MALEATE | ANDA220447 | Approved | Drugs@FDA ↗ |
| 21 Jul 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
BUPROPION HYDROCHLORIDE | ANDA216051 | Approved | Drugs@FDA ↗ |
| 17 Jul 2026 | Dr. Reddy's Laboratories DR REDDYS LABS LTD |
SITAGLIPTIN PHOSPHATE | ANDA214700 | Tentative | Drugs@FDA ↗ |
| 16 Jul 2026 | Ajanta Pharma AJANTA PHARMA LTD |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
ANDA215220 | Tentative | Drugs@FDA ↗ |
| 15 Jul 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
ETODOLAC | ANDA214872 | Approved | Drugs@FDA ↗ |
| 13 Jul 2026 | Biocon BIOCON PHARMA LIMITED |
PALBOCICLIB | ANDA220120 | Tentative | Drugs@FDA ↗ |
| 13 Jul 2026 | Natco Pharma NATCO PHARMA LIMITED |
ANDA216768 | Tentative | Drugs@FDA ↗ | |
| 09 Jul 2026 | Laurus Labs LAURUS LABS LTD |
TENOFOVIR ALAFENAMIDE FUMARATE | ANDA214030 | Tentative | Drugs@FDA ↗ |
| 09 Jul 2026 | Ajanta Pharma AJANTA PHARMA LTD |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE METFORMIN HYDROCHLORIDE, SITAGLIPTIN |
ANDA216516 | Tentative | Drugs@FDA ↗ |
| 09 Jul 2026 | Glenmark Pharmaceuticals GLENMARK PHARMS LTD |
NINTEDANIB ESYLATE | ANDA212555 | Approved | Drugs@FDA ↗ |
| 01 Jul 2026 | Mankind Pharma MANKIND PHARMA |
RIVAROXABAN | ANDA220874 | Approved | Drugs@FDA ↗ |
| 30 Jun 2026 | Zydus Lifesciences ZYDUS PHARMS USA INC |
METFORMIN HYDROCHLORIDE AND SITAGLIPTIN PHOSPHATE METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE |
ANDA208535 | Tentative | Drugs@FDA ↗ |
| 30 Jun 2026 | Zydus Lifesciences ZYDUS PHARMS |
SELENIOUS ACID | ANDA219322 | Approved | Drugs@FDA ↗ |
| 26 Jun 2026 | Dr. Reddy's Laboratories DR REDDYS |
PREDNISONE | ANDA218035 | Approved | Drugs@FDA ↗ |
| 26 Jun 2026 | Zydus Lifesciences ZYDUS PHARMS USA INC |
CARBIDOPA; LEODOPA CARBIDOPA, LEODOPA |
ANDA210911 | Tentative | Drugs@FDA ↗ |
| 24 Jun 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
ICOSAPENT ETHYL | ANDA218949 | Approved | Drugs@FDA ↗ |
| 11 Jun 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA212374 | Tentative | Drugs@FDA ↗ |
| 10 Jun 2026 | Alembic Pharmaceuticals ALEMBIC PHARMACEUTICALS LIMITED |
LAROTRECTINIB | ANDA220639 | Tentative | Drugs@FDA ↗ |
| 09 Jun 2026 | Aurobindo Pharma AUROBINDO PHARMA |
CEPHALEXIN | ANDA213568 | Approved | Drugs@FDA ↗ |
| 09 Jun 2026 | Concord Biotech CONCORD BIOTECH LTD |
TOFACITINIB CITRATE | ANDA218821 | Approved | Drugs@FDA ↗ |
| 05 Jun 2026 | Zydus Lifesciences ZYDUS PHARMS |
TOFACITINIB CITRATE | ANDA209829 | Approved | Drugs@FDA ↗ |
| 03 Jun 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
TOFACITINIB CITRATE | ANDA215356 | Approved | Drugs@FDA ↗ |
| 02 Jun 2026 | Aurobindo Pharma AUROBINDO PHARMA |
ELUXADOLINE | ANDA213511 | Approved | Drugs@FDA ↗ |
| 02 Jun 2026 | Lupin LUPIN LIMITED |
RANLUSPEC RANIBIZUMAB-HKDZ |
BLA761480 | Approved | Drugs@FDA ↗ |
| 01 Jun 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
FLUORESCEIN SODIUM | ANDA218651 | Approved | Drugs@FDA ↗ |
| 29 May 2026 | Wockhardt WOCKHARDT BIO AG |
ZAYNICH CEFEPIME HYDROCHLORIDE, ZIDEBACTAM |
NDA220787 | Approved | Drugs@FDA ↗ |
| 28 May 2026 | Lupin LUPIN |
SODIUM SULFATE, MAGNESIUM SULFATE AND POTASSIUM CHLORIDE MAGNESIUM SULFATE, POTASSIUM CHLORIDE, SODIUM SULFATE |
ANDA216095 | Approved | Drugs@FDA ↗ |
| 28 May 2026 | Biocon BIOCON PHARMA |
DEFLAZACORT | ANDA220709 | Approved | Drugs@FDA ↗ |
| 28 May 2026 | Zydus Lifesciences ZYDUS PHARMACEUTICALS (USA) INC. |
ANDA220724 | Tentative | Drugs@FDA ↗ | |
| 21 May 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
EMPAGLIFLOZIN | ANDA212371 | Tentative | Drugs@FDA ↗ |
| 21 May 2026 | Mankind Pharma MANKIND PHARMA LTD |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE SITAGLIPTIN, METFORMIN HYDROCHLORIDE |
ANDA218405 | Tentative | Drugs@FDA ↗ |
| 15 May 2026 | Dr. Reddy's Laboratories DR REDDYS |
VENETOCLAX | ANDA214733 | Approved | Drugs@FDA ↗ |
| 15 May 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
AMMONIUM LACTATE | ANDA217758 | Approved | Drugs@FDA ↗ |
| 15 May 2026 | Lupin LUPIN INC. |
REVEFENACIN | ANDA218088 | Tentative | Drugs@FDA ↗ |
| 15 May 2026 | Jubilant Pharmova JUBILANT GENERICS |
TADALAFIL | ANDA210329 | Approved | Drugs@FDA ↗ |
| 15 May 2026 | Dr. Reddy's Laboratories DR. REDDY'S LABORATORIES LIMITED |
PALBOCICLIB | ANDA220444 | Tentative | Drugs@FDA ↗ |
| 15 May 2026 | Dr. Reddy's Laboratories DR REDDYS |
PHYTONADIONE | ANDA215820 | Approved | Drugs@FDA ↗ |
| 14 May 2026 | Zydus Lifesciences ZYDUS PHARMACEUTICALS (USA) INC. |
UBROGEPANT | ANDA218662 | Tentative | Drugs@FDA ↗ |
| 13 May 2026 | Caplin Point Laboratories CAPLIN |
FOSCARNET SODIUM | ANDA220068 | Approved | Drugs@FDA ↗ |
| 13 May 2026 | Alembic Pharmaceuticals ALEMBIC PHARMACEUTICALS LIMITED |
ANDA220499 | Tentative | Drugs@FDA ↗ | |
| 12 May 2026 | Lupin LUPIN |
FAMOTIDINE | ANDA217432 | Approved | Drugs@FDA ↗ |
| 07 May 2026 | Dr. Reddy's Laboratories DR REDDYS LABS LTD |
ANDA212336 | Tentative | Drugs@FDA ↗ | |
| 07 May 2026 | Zydus Lifesciences ZYDUS PHARMS |
HYDROCORTISONE SODIUM SUCCINATE | ANDA217191 | Approved | Drugs@FDA ↗ |
| 04 May 2026 | Caplin Point Laboratories CAPLIN |
CALCIUM GLUCONATE | ANDA218840 | Approved | Drugs@FDA ↗ |
| 01 May 2026 | Biocon BIOCON PHARMA LTD |
SITAGLIPTIN | ANDA218441 | Tentative | Drugs@FDA ↗ |
| 30 Apr 2026 | Lupin LUPIN |
GLYCEROL PHENYLBUTYRATE | ANDA207694 | Approved | Drugs@FDA ↗ |
| 28 Apr 2026 | Biocon BIOCON PHARMA |
ELTROMBOPAG OLAMINE | ANDA220660 | Approved | Drugs@FDA ↗ |
| 28 Apr 2026 | Sun Pharmaceutical Industries SUN PHARMA CANADA |
DOXEPIN HYDROCHLORIDE | ANDA213919 | Approved | Drugs@FDA ↗ |
| 28 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
CENOBAMATE | ANDA219473 | Tentative | Drugs@FDA ↗ |
| 22 Apr 2026 | Cipla CIPLA |
ALBUTEROL SULFATE | ANDA219409 | Approved | Drugs@FDA ↗ |
| 20 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA |
PIRFENIDONE | ANDA212597 | Approved | Drugs@FDA ↗ |
| 20 Apr 2026 | Torrent Pharmaceuticals TORRENT PHARMACEUTICALS LTD |
VERICIGUAT | ANDA220221 | Tentative | Drugs@FDA ↗ |
| 20 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CANAGLIFLOZIN | ANDA210386 | Approved | Drugs@FDA ↗ |
| 17 Apr 2026 | Dr. Reddy's Laboratories DR REDDYS |
SODIUM ACETATE | ANDA220274 | Approved | Drugs@FDA ↗ |
| 16 Apr 2026 | Mankind Pharma MANKIND PHARMA |
BRIMONIDINE TARTRATE | ANDA220398 | Approved | Drugs@FDA ↗ |
| 15 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
DEXTROMETHORPHAN POLISTIREX | ANDA218417 | Approved | Drugs@FDA ↗ |
| 15 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA |
GLYCEROL PHENYLBUTYRATE | ANDA220313 | Approved | Drugs@FDA ↗ |
| 08 Apr 2026 | Glenmark Pharmaceuticals GLENMARK PHARMS |
PROGESTERONE | ANDA216363 | Approved | Drugs@FDA ↗ |
| 07 Apr 2026 | Ajanta Pharma AJANTA PHARMA LTD |
IVERMECTIN | ANDA218509 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Zydus Lifesciences ZYDUS PHARMS |
DAPAGLIFLOZIN | ANDA211582 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA |
DAPAGLIFLOZIN | ANDA211468 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Biocon BIOCON PHARMA |
DAPAGLIFLOZIN | ANDA211470 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Cipla CIPLA LTD |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA211536 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Cipla CIPLA |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA211595 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Cipla CIPLA |
DAPAGLIFLOZIN | ANDA211535 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Ajanta Pharma AJANTA PHARMA LTD |
DAPAGLIFLOZIN | ANDA211482 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Lupin LUPIN |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA211579 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Lupin LUPIN |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA211579 | Tentative | Drugs@FDA ↗ |
| 06 Apr 2026 | Lupin LUPIN |
DAPAGLIFLOZIN | ANDA211531 | Approved | Drugs@FDA ↗ |
| 06 Apr 2026 | Aurobindo Pharma AUROBINDO PHARMA |
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE DAPAGLIFLOZIN, DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE |
ANDA211489 | Approved | Drugs@FDA ↗ |
| 02 Apr 2026 | Dr. Reddy's Laboratories DR REDDYS |
NINTEDANIB ESYLATE | ANDA219283 | Approved | Drugs@FDA ↗ |
| 02 Apr 2026 | Cipla CIPLA |
NINTEDANIB ESYLATE | ANDA212609 | Approved | Drugs@FDA ↗ |
| 25 Mar 2026 | Natco Pharma NATCO PHARMA LTD |
ANDA217383 | Tentative | Drugs@FDA ↗ | |
| 24 Mar 2026 | Alkem Laboratories ALKEM LABORATORIES LIMITED |
ANDA220352 | Tentative | Drugs@FDA ↗ | |
| 23 Mar 2026 | Torrent Pharmaceuticals TORRENT PHARMACEUTICALS LTD |
RUXOLITINIB | ANDA220375 | Tentative | Drugs@FDA ↗ |
| 23 Mar 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CEFIXIME | ANDA217607 | Approved | Drugs@FDA ↗ |
| 20 Mar 2026 | Ajanta Pharma AJANTA PHARMA LTD |
TOFACITINIB CITRATE | ANDA212943 | Approved | Drugs@FDA ↗ |
| 20 Mar 2026 | Alkem Laboratories ALKEM LABORATORIES LIMITED |
RIFAXIMIN | ANDA220451 | Tentative | Drugs@FDA ↗ |
| 19 Mar 2026 | Natco Pharma NATCO PHARMA LTD |
PALBOCICLIB | ANDA213089 | Tentative | Drugs@FDA ↗ |
| 18 Mar 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CLINDAMYCIN PHOSPHATE | ANDA218942 | Approved | Drugs@FDA ↗ |
| 17 Mar 2026 | Biocon BIOCON PHARMA LIMITED |
CABOZANTINIB | ANDA220121 | Tentative | Drugs@FDA ↗ |
| 16 Mar 2026 | Cipla CIPLA LTD |
RIFAXIMIN | ANDA219570 | Tentative | Drugs@FDA ↗ |
| 16 Mar 2026 | Dr. Reddy's Laboratories DR REDDYS |
ELTROMBOPAG, ELTROMBOPAG OLAMINE | ANDA219121 | Approved | Drugs@FDA ↗ |
| 16 Mar 2026 | Glenmark Pharmaceuticals GLENMARK SPECLT |
FLUTICASONE PROPIONATE | ANDA218742 | Approved | Drugs@FDA ↗ |
| 13 Mar 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CITALOPRAM HYDROBROMIDE | ANDA219985 | Approved | Drugs@FDA ↗ |
| 12 Mar 2026 | Caplin Point Laboratories CAPLIN |
POTASSIUM PHOSPHATES POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM PHOSPHATE, MONOBASIC |
ANDA220373 | Approved | Drugs@FDA ↗ |
| 11 Mar 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
CEVIMELINE HYDROCHLORIDE | ANDA220267 | Approved | Drugs@FDA ↗ |
| 11 Mar 2026 | Biocon BIOCON PHARMA |
LIRAGLUTIDE | ANDA215245 | Approved | Drugs@FDA ↗ |
| 06 Mar 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
SIPONIMOD | ANDA218459 | Approved | Drugs@FDA ↗ |
| 04 Mar 2026 | Zydus Lifesciences ZYDUS PHARMS |
CALCITONIN-SALMON CALCITONIN SALMON |
ANDA215864 | Approved | Drugs@FDA ↗ |
| 03 Mar 2026 | Glenmark Pharmaceuticals GLENMARK SPECLT |
FLUTICASONE PROPIONATE | ANDA219602 | Approved | Drugs@FDA ↗ |
| 02 Mar 2026 | Gland Pharma GLAND PHARMA LIMITED |
ANDA220091 | Tentative | Drugs@FDA ↗ | |
| 27 Feb 2026 | Caplin Point Laboratories CAPLIN |
DESMOPRESSIN ACETATE | ANDA219981 | Approved | Drugs@FDA ↗ |
| 26 Feb 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
DAPSONE | ANDA220103 | Approved | Drugs@FDA ↗ |
| 26 Feb 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
IVERMECTIN | ANDA216863 | Approved | Drugs@FDA ↗ |
| 25 Feb 2026 | Natco Pharma NATCO PHARMA LTD |
ANDA217441 | Tentative | Drugs@FDA ↗ | |
| 25 Feb 2026 | Dr. Reddy's Laboratories DR REDDYS |
DEXMEDETOMIDINE HYDROCHLORIDE | ANDA220315 | Approved | Drugs@FDA ↗ |
| 25 Feb 2026 | Ajanta Pharma AJANTA PHARMA LTD |
EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE |
ANDA220511 | Tentative | Drugs@FDA ↗ |
| 25 Feb 2026 | Cipla CIPLA LIMITED |
PALBOCICLIB | ANDA212980 | Tentative | Drugs@FDA ↗ |
| 25 Feb 2026 | Aurobindo Pharma EUGIA PHARMA |
EVEROLIMUS | ANDA219533 | Approved | Drugs@FDA ↗ |
| 24 Feb 2026 | Caplin Point Laboratories CAPLIN |
PREGABALIN | ANDA218529 | Approved | Drugs@FDA ↗ |
| 24 Feb 2026 | Biocon BIOCON PHARMA |
LIRAGLUTIDE | ANDA217063 | Approved | Drugs@FDA ↗ |
| 24 Feb 2026 | Ajanta Pharma AJANTA PHARMA LTD |
SITAGLIPTIN PHOSPHATE | ANDA214784 | Tentative | Drugs@FDA ↗ |
| 24 Feb 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE | ANDA214859 | Tentative | Drugs@FDA ↗ |
| 23 Feb 2026 | Caplin Point Laboratories CAPLIN |
SODIUM PHOSPHATES SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE |
ANDA220683 | Approved | Drugs@FDA ↗ |
| 23 Feb 2026 | Lupin LUPIN |
BRIVARACETAM | ANDA220164 | Approved | Drugs@FDA ↗ |
| 18 Feb 2026 | Aurobindo Pharma AUROBINDO PHARMA |
ARIPIPRAZOLE | ANDA216208 | Approved | Drugs@FDA ↗ |
| 17 Feb 2026 | Zydus Lifesciences ZYDUS PHARMS |
BOSENTAN | ANDA213981 | Approved | Drugs@FDA ↗ |
| 13 Feb 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
METRONIDAZOLE | ANDA220095 | Approved | Drugs@FDA ↗ |
| 12 Feb 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
AMMONIUM LACTATE | ANDA217815 | Approved | Drugs@FDA ↗ |
| 10 Feb 2026 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
ANDA217786 | Tentative | Drugs@FDA ↗ | |
| 09 Feb 2026 | Ajanta Pharma AJANTA PHARMA LTD |
METHAZOLAMIDE | ANDA217408 | Approved | Drugs@FDA ↗ |
| 06 Feb 2026 | Mankind Pharma MANKIND PHARMA |
TICAGRELOR | ANDA217679 | Approved | Drugs@FDA ↗ |
| 04 Feb 2026 | Aurobindo Pharma EUGIA PHARMA SPECLTS |
NINTEDANIB | ANDA215123 | Tentative | Drugs@FDA ↗ |
| 04 Feb 2026 | Mankind Pharma MANKIND PHARMA |
ANDA212283 | Tentative | Drugs@FDA ↗ | |
| 02 Feb 2026 | Natco Pharma NATCO PHARMA LTD |
ERDAFITINIB | ANDA218578 | Tentative | Drugs@FDA ↗ |
| 02 Feb 2026 | Cipla CIPLA |
LENALIDOMIDE | ANDA213165 | Approved | Drugs@FDA ↗ |
| 29 Jan 2026 | Zydus Lifesciences ZYDUS LIFESCIENCES |
SERTRALINE HYDROCHLORIDE | ANDA220275 | Approved | Drugs@FDA ↗ |
| 27 Jan 2026 | Mankind Pharma MANKIND PHARMA |
PROPRANOLOL HYDROCHLORIDE | ANDA216663 | Approved | Drugs@FDA ↗ |
| 27 Jan 2026 | Aurobindo Pharma EUGIA PHARMA |
MESNA | ANDA220518 | Approved | Drugs@FDA ↗ |
| 26 Jan 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
BETAMETHASONE DIPROPIONATE | ANDA219348 | Approved | Drugs@FDA ↗ |
| 26 Jan 2026 | Caplin Point Laboratories CAPLIN |
METHYLPREDNISOLONE ACETATE | ANDA220556 | Approved | Drugs@FDA ↗ |
| 21 Jan 2026 | Aurobindo Pharma AUROBINDO PHARMA LTD |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE |
ANDA217922 | Approved | Drugs@FDA ↗ |
| 21 Jan 2026 | Glenmark Pharmaceuticals GLENMARK PHARMS |
LACOSAMIDE | ANDA220268 | Approved | Drugs@FDA ↗ |
| 16 Jan 2026 | Ajanta Pharma AJANTA PHARMA LTD |
PRUCALOPRIDE SUCCINATE | ANDA219220 | Approved | Drugs@FDA ↗ |
| 14 Jan 2026 | Zydus Lifesciences ZYDUS PHARMS |
ELTROMBOPAG OLAMINE | ANDA216281 | Approved | Drugs@FDA ↗ |
| 09 Jan 2026 | Biocon BIOCON PHARMA |
EVEROLIMUS | ANDA217216 | Approved | Drugs@FDA ↗ |
| 07 Jan 2026 | Granules India GRANULES PHARMACEUTICALS INC |
AMPHETAMINE | ANDA220284 | Tentative | Drugs@FDA ↗ |
| 05 Jan 2026 | Glenmark Pharmaceuticals GLENMARK PHARMS LTD |
SUCRALFATE | ANDA212141 | Approved | Drugs@FDA ↗ |
| 02 Jan 2026 | Mankind Pharma MANKIND PHARMA |
EXTENDED PHENYTOIN SODIUM PHENYTOIN SODIUM |
ANDA219773 | Approved | Drugs@FDA ↗ |
| 29 Dec 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
PSEUDOEPHEDRINE HYDROCHLORIDE | ANDA218854 | Approved | Drugs@FDA ↗ |
| 29 Dec 2025 | Aurobindo Pharma AUROBINDO PHARMA |
LOPERAMIDE HYDROCHLORIDE | ANDA220372 | Approved | Drugs@FDA ↗ |
| 22 Dec 2025 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
ANDA219328 | Tentative | Drugs@FDA ↗ | |
| 19 Dec 2025 | Granules India GRANULES PHARMACEUTICALS INC |
AMPHETAMINE | ANDA219800 | Tentative | Drugs@FDA ↗ |
| 17 Dec 2025 | Mankind Pharma MANKIND PHARMA |
LATANOPROST | ANDA220360 | Approved | Drugs@FDA ↗ |
| 16 Dec 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
CARIPRAZINE HYDROCHLORIDE | ANDA213982 | Approved | Drugs@FDA ↗ |
| 08 Dec 2025 | Caplin Point Laboratories CAPLIN |
LINEZOLID | ANDA219558 | Approved | Drugs@FDA ↗ |
| 05 Dec 2025 | Caplin Point Laboratories CAPLIN |
ACETAMINOPHEN | ANDA219096 | Approved | Drugs@FDA ↗ |
| 28 Nov 2025 | Lupin LUPIN LTD |
ARMLUPEG PEGFILGRASTIM-UNNE |
BLA761212 | Approved | Drugs@FDA ↗ |
| 25 Nov 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE EMPAGLIFLOZIN, LINAGLIPTIN, METFORMIN HYDROCHLORIDE |
ANDA217049 | Tentative | Drugs@FDA ↗ |
| 25 Nov 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
ANDA213345 | Tentative | Drugs@FDA ↗ | |
| 24 Nov 2025 | Zydus Lifesciences ZYDUS LIFESCIENCES |
VERAPAMIL HYDROCHLORIDE | ANDA219252 | Approved | Drugs@FDA ↗ |
| 20 Nov 2025 | Aurobindo Pharma AUROBINDO PHARMA |
POTASSIUM CHLORIDE | ANDA216536 | Approved | Drugs@FDA ↗ |
| 19 Nov 2025 | Dr. Reddy's Laboratories DR REDDYS |
NILOTINIB HYDROCHLORIDE | ANDA218350 | Approved | Drugs@FDA ↗ |
| 17 Nov 2025 | Biocon BIOCON PHARMA |
TOFACITINIB CITRATE | ANDA219442 | Approved | Drugs@FDA ↗ |
| 17 Nov 2025 | Biocon BIOCON PHARMA |
TOFACITINIB CITRATE | ANDA219442 | Tentative | Drugs@FDA ↗ |
| 14 Nov 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
FOSFOMYCIN TROMETHAMINE | ANDA217608 | Approved | Drugs@FDA ↗ |
| 13 Nov 2025 | Zydus Lifesciences ZYDUS PHARMS |
LEUPROLIDE ACETATE | ANDA215826 | Approved | Drugs@FDA ↗ |
| 12 Nov 2025 | Zydus Lifesciences ZYDUS |
DIROXIMEL FUMARATE | ANDA218596 | Approved | Drugs@FDA ↗ |
| 12 Nov 2025 | Laurus Labs LAURUS LABS LTD |
SITAGLIPTIN | ANDA216057 | Tentative | Drugs@FDA ↗ |
| 06 Nov 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
OLAPARIB | ANDA219893 | Tentative | Drugs@FDA ↗ |
| 04 Nov 2025 | Alkem Laboratories ALKEM LABORATORIES LIMITED |
ANDA219416 | Tentative | Drugs@FDA ↗ | |
| 03 Nov 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
LINAGLIPTIN | ANDA208415 | Approved | Drugs@FDA ↗ |
| 03 Nov 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
ANDA218685 | Tentative | Drugs@FDA ↗ | |
| 03 Nov 2025 | Dr. Reddy's Laboratories DR REDDYS |
LINAGLIPTIN | ANDA208428 | Approved | Drugs@FDA ↗ |
| 03 Nov 2025 | Dr. Reddy's Laboratories DR REDDYS |
LINAGLIPTIN AND METFORMIN HYDROCHLORIDE LINAGLIPTIN, METFORMIN HYDROCHLORIDE |
ANDA208427 | Approved | Drugs@FDA ↗ |
| 03 Nov 2025 | Cipla CIPLA |
ANDA215897 | Tentative | Drugs@FDA ↗ | |
| 31 Oct 2025 | Indoco Remedies INDOCO REMEDIES |
ANDA210312 | Tentative | Drugs@FDA ↗ | |
| 29 Oct 2025 | Biocon BIOCON BIOLOGICS INC |
AUKELSO, BOSAYA DENOSUMAB-KYQQ |
BLA761436 | Approved | Drugs@FDA ↗ |
| 28 Oct 2025 | Dr. Reddy's Laboratories DR REDDYS |
TICAGRELOR | ANDA208541 | Approved | Drugs@FDA ↗ |
| 23 Oct 2025 | Alkem Laboratories ALKEM LABORATORIES LIMITED |
BEMPEDOIC ACID AND EZETIMIBE BEMPEDOIC ACID, EZETIMIBE |
ANDA219421 | Tentative | Drugs@FDA ↗ |
| 23 Oct 2025 | Dr. Reddy's Laboratories DR REDDYS |
DOCOSANOL | ANDA215505 | Approved | Drugs@FDA ↗ |
| 22 Oct 2025 | Caplin Point Laboratories CAPLIN |
NICARDIPINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE NICARDIPINE HYDROCHLORIDE |
ANDA220243 | Approved | Drugs@FDA ↗ |
| 14 Oct 2025 | Cipla CIPLA LTD |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | ANDA218766 | Tentative | Drugs@FDA ↗ |
| 10 Oct 2025 | Cipla CIPLA LIMITED |
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE EMTRICITABINE, TENOFOVIR ALAFENAMIDE |
ANDA211680 | Tentative | Drugs@FDA ↗ |
| 03 Oct 2025 | Aurobindo Pharma AUROBINDO PHARMA |
NAPROXEN | ANDA216504 | Approved | Drugs@FDA ↗ |
| 03 Oct 2025 | Dr. Reddy's Laboratories DR REDDYS |
DOCOSANOL | ANDA214613 | Approved | Drugs@FDA ↗ |
| 03 Oct 2025 | Zydus Lifesciences ZYDUS LIFESCIENCES |
DEFLAZACORT | ANDA220042 | Approved | Drugs@FDA ↗ |
| 01 Oct 2025 | Dr. Reddy's Laboratories DR REDDYS |
PREDNISONE | ANDA219477 | Approved | Drugs@FDA ↗ |
| 29 Sep 2025 | Laurus Labs LAURUS LABS LTD |
CANAGLIFLOZIN | ANDA210503 | Tentative | Drugs@FDA ↗ |
| 25 Sep 2025 | Lupin LUPIN |
RIVAROXABAN | ANDA218195 | Approved | Drugs@FDA ↗ |
| 16 Sep 2025 | Biocon BIOCON BIOLOGICS INC |
AUKELSO, BOSAYA DENOSUMAB-KYQQ |
BLA761436 | Approved | Drugs@FDA ↗ |
| 16 Sep 2025 | Lupin LUPIN |
LENALIDOMIDE | ANDA214398 | Approved | Drugs@FDA ↗ |
| 15 Sep 2025 | Cipla CIPLA |
GLUCAGON | ANDA218813 | Approved | Drugs@FDA ↗ |
| 08 Sep 2025 | Aurobindo Pharma AUROBINDO PHARMA |
DEFERASIROX | ANDA215137 | Approved | Drugs@FDA ↗ |
| 08 Sep 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
PROCHLORPERAZINE MALEATE | ANDA218734 | Approved | Drugs@FDA ↗ |
| 02 Sep 2025 | Ajanta Pharma AJANTA PHARMA LTD |
TOPIRAMATE | ANDA219564 | Approved | Drugs@FDA ↗ |
| 02 Sep 2025 | Caplin Point Laboratories CAPLIN |
MILRINONE LACTATE IN DEXTROSE 5% MILRINONE LACTATE |
ANDA219170 | Approved | Drugs@FDA ↗ |
| 25 Aug 2025 | Lupin LUPIN |
DASATINIB | ANDA214350 | Approved | Drugs@FDA ↗ |
| 19 Aug 2025 | Ajanta Pharma AJANTA PHARMA LTD |
TOFACITINIB CITRATE | ANDA219542 | Approved | Drugs@FDA ↗ |
| 12 Aug 2025 | Mankind Pharma MANKIND PHARMA |
DIVALPROEX SODIUM | ANDA217358 | Approved | Drugs@FDA ↗ |
| 11 Aug 2025 | Aurobindo Pharma AUROBINDO PHARMA |
PIRFENIDONE | ANDA212596 | Approved | Drugs@FDA ↗ |
| 08 Aug 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
CARBIDOPA; LEODOPA CARBIDOPA, LEODOPA |
ANDA210911 | Tentative | Drugs@FDA ↗ |
| 08 Aug 2025 | Zydus Lifesciences ZYDUS LIFESCIENCES |
DILTIAZEM HYDROCHLORIDE | ANDA219253 | Approved | Drugs@FDA ↗ |
| 07 Aug 2025 | Zydus Lifesciences ZYDUS LIFESCIENCES |
PRUCALOPRIDE SUCCINATE | ANDA218056 | Approved | Drugs@FDA ↗ |
| 07 Aug 2025 | Caplin Point Laboratories CAPLIN |
KETAMINE HYDROCHLORIDE | ANDA217858 | Approved | Drugs@FDA ↗ |
| 06 Aug 2025 | Dr. Reddy's Laboratories DR. REDDY'S LABORATORIES LIMITED |
LUMATEPERONE | ANDA219229 | Tentative | Drugs@FDA ↗ |
| 05 Aug 2025 | Jubilant Pharmova JUBILANT GENERICS |
BUMETANIDE | ANDA212470 | Approved | Drugs@FDA ↗ |
| 05 Aug 2025 | Glenmark Pharmaceuticals GLENMARK PHARMS |
ERIBULIN MESYLATE | ANDA218142 | Approved | Drugs@FDA ↗ |
| 04 Aug 2025 | Jubilant Pharmova JUBILANT GENERICS |
ESLICARBAZEPINE ACETATE | ANDA211219 | Approved | Drugs@FDA ↗ |
| 29 Jul 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
LIDOCAINE HYDROCHLORIDE | ANDA219759 | Approved | Drugs@FDA ↗ |
| 22 Jul 2025 | Lupin LUPIN |
LIRAGLUTIDE | ANDA215421 | Approved | Drugs@FDA ↗ |
| 22 Jul 2025 | Zydus Lifesciences ZYDUS WORLDWIDE DMCC |
IBRUTINIB | ANDA214296 | Tentative | Drugs@FDA ↗ |
| 22 Jul 2025 | Lupin LUPIN |
GLUCAGON | ANDA214457 | Approved | Drugs@FDA ↗ |
| 21 Jul 2025 | Cipla CIPLA |
SELENIOUS ACID | ANDA218661 | Approved | Drugs@FDA ↗ |
| 21 Jul 2025 | Glenmark Pharmaceuticals GLENMARK PHARMS LTD |
ANDA213235 | Tentative | Drugs@FDA ↗ | |
| 17 Jul 2025 | Dr. Reddy's Laboratories DR REDDYS LABS SA |
HABITROL NICOTINE POLACRILEX |
ANDA215276 | Approved | Drugs@FDA ↗ |
| 17 Jul 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
FUROSEMIDE | ANDA218831 | Approved | Drugs@FDA ↗ |
| 15 Jul 2025 | Biocon BIOCON BIOLOGICS INC |
KIRSTY INSULIN ASPART-XJHZ |
BLA761188 | Approved | Drugs@FDA ↗ |
| 14 Jul 2025 | Zydus Lifesciences ZYDUS PHARMS |
CELECOXIB | ANDA205938 | Approved | Drugs@FDA ↗ |
| 09 Jul 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
FAMOTIDINE | ANDA219091 | Approved | Drugs@FDA ↗ |
| 09 Jul 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
METRONIDAZOLE | ANDA219295 | Approved | Drugs@FDA ↗ |
| 03 Jul 2025 | Dr. Reddy's Laboratories DR REDDYS |
ERIBULIN MESYLATE | ANDA217473 | Approved | Drugs@FDA ↗ |
| 01 Jul 2025 | Dr. Reddy's Laboratories DR REDDYS |
DOXYCYCLINE HYCLATE | ANDA218753 | Approved | Drugs@FDA ↗ |
| 30 Jun 2025 | Lupin LUPIN |
LOTEPREDNOL ETABONATE | ANDA218087 | Approved | Drugs@FDA ↗ |
| 30 Jun 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
IBUPROFEN AND FAMOTIDINE FAMOTIDINE, IBUPROFEN |
ANDA219538 | Approved | Drugs@FDA ↗ |
| 30 Jun 2025 | Cipla CIPLA LIMITED |
ABACAVIR, DOLUTEGRAVIR, LAMIVUDINE | ANDA210391 | Tentative | Drugs@FDA ↗ |
| 25 Jun 2025 | Gland Pharma GLAND PHARMA LIMITED |
ZINC SULFATE HEPTAHYDRATE, CUPRIC SULFATE, MANGANESE SULFATE, SELENIOUS ACID | ANDA219632 | Tentative | Drugs@FDA ↗ |
| 24 Jun 2025 | Cipla CIPLA LTD |
BICTEGRAVIR, EMTRICITABINE AND TENOFOVIR ALAFENAMIDE | ANDA216914 | Tentative | Drugs@FDA ↗ |
| 24 Jun 2025 | Lupin LUPIN |
PRUCALOPRIDE SUCCINATE | ANDA218847 | Approved | Drugs@FDA ↗ |
| 12 Jun 2025 | Emcure Pharmaceuticals EMCURE PHARMS LTD |
DOLUTEGRAVIR AND LAMIVUDINE | ANDA219623 | Tentative | Drugs@FDA ↗ |
| 12 Jun 2025 | Dr. Reddy's Laboratories DR REDDYS LABS SA |
PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE PHENTERMINE HYDROCHLORIDE, TOPIRAMATE |
ANDA208175 | Approved | Drugs@FDA ↗ |
| 12 Jun 2025 | Cipla CIPLA LIMITED |
DOLUTEGRAVIR SODIUM AND ABACAVIR SULFATE AND LAMIVUDINE ABACAVIR || DOLUTEGRAVIR || LAMIVUDINE |
ANDA210811 | Tentative | Drugs@FDA ↗ |
| 09 Jun 2025 | Aurobindo Pharma AUROBINDO PHARMA |
SAPROPTERIN DIHYDROCHLORIDE | ANDA216797 | Approved | Drugs@FDA ↗ |
| 06 Jun 2025 | Lupin LUPIN LIMITED |
OXCARBAZEPINE EXTENDED RELEASE TABLETS OXCARBAZEPINE |
ANDA219404 | Tentative | Drugs@FDA ↗ |
| 05 Jun 2025 | Dr. Reddy's Laboratories DR REDDYS LABS LTD |
SIPONIMOD | ANDA218393 | Tentative | Drugs@FDA ↗ |
| 02 Jun 2025 | Cipla CIPLA LIMITED |
OLAPARIB | ANDA219410 | Tentative | Drugs@FDA ↗ |
| 30 May 2025 | Dr. Reddy's Laboratories DR REDDYS LABS SA |
PHENYLEPHRINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE PHENYLEPHRINE HYDROCHLORIDE |
NDA216830 | Approved | Drugs@FDA ↗ |
| 30 May 2025 | Dr. Reddy's Laboratories DR REDDYS LABS LTD |
ANDA214685 | Tentative | Drugs@FDA ↗ | |
| 30 May 2025 | Zydus Lifesciences ZYDUS PHARMS USA INC |
RIFAXIMIN | ANDA218650 | Tentative | Drugs@FDA ↗ |
| 30 May 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
ACETAZOLAMIDE | ANDA212089 | Approved | Drugs@FDA ↗ |
| 29 May 2025 | Mankind Pharma MANKIND PHARMA |
ROCURONIUM BROMIDE | ANDA219674 | Approved | Drugs@FDA ↗ |
| 28 May 2025 | Aurobindo Pharma AUROBINDO PHARMA LIMITED |
UBROGEPANT | ANDA219088 | Tentative | Drugs@FDA ↗ |
| 22 May 2025 | Zydus Lifesciences ZYDUS PHARMS |
ISOTRETINOIN | ANDA216633 | Approved | Drugs@FDA ↗ |
| 21 May 2025 | Mankind Pharma MANKIND PHARMA |
PROPARACAINE HYDROCHLORIDE | ANDA219136 | Approved | Drugs@FDA ↗ |
| 20 May 2025 | Jubilant Pharmova JUBILANT GENERICS |
PREGABALIN | ANDA209530 | Approved | Drugs@FDA ↗ |
| 19 May 2025 | Dr. Reddy's Laboratories DR REDDYS LABS SA |
PROCHLORPERAZINE MALEATE | ANDA217847 | Approved | Drugs@FDA ↗ |
| 16 May 2025 | Mankind Pharma MANKIND PHARMA |
ROSUVASTATIN CALCIUM | ANDA206603 | Approved | Drugs@FDA ↗ |
| 16 May 2025 | Cipla CIPLA |
GEFITINIB | ANDA211826 | Approved | Drugs@FDA ↗ |
| 15 May 2025 | Aurobindo Pharma AUROBINDO PHARMA LTD |
RIVAROXABAN | ANDA208544 | Approved | Drugs@FDA ↗ |
| 14 May 2025 | Dr. Reddy's Laboratories DR REDDYS |
RIVAROXABAN | ANDA208534 | Approved | Drugs@FDA ↗ |
| 14 May 2025 | Aurobindo Pharma AUROBINDO PHARMA |
DABIGATRAN ETEXILATE MESYLATE | ANDA208039 | Approved | Drugs@FDA ↗ |
| 14 May 2025 | Lupin LUPIN |
RIVAROXABAN | ANDA208555 | Approved | Drugs@FDA ↗ |
| 14 May 2025 | Biocon BIOCON PHARMA |
RIVAROXABAN | ANDA218107 | Approved | Drugs@FDA ↗ |
| 13 May 2025 | Caplin Point Laboratories CAPLIN |
HALOPERIDOL DECANOATE | ANDA219168 | Approved | Drugs@FDA ↗ |
| 12 May 2025 | Ajanta Pharma AJANTA PHARMA LTD |
TERAZOSIN HYDROCHLORIDE | ANDA219482 | Approved | Drugs@FDA ↗ |