Fda

FDA drug approvals recorded by openFDA between 2026-09-27 and 2026-10-11, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-10-07 Actavis Pharma, Inc. ISOTRETINOIN n/a 2026-10-07 Amneal Pharmaceuticals LLC ISOTRETINOIN AMRX 2026-10-07 AUROBINDO PHARMA LTD ISOTRETINOIN n/a 2026-10-07 BluePoint Laboratories ZENATANE n/a 2026-10-07 Mayne Pharma ISOTRETINOIN n/a 2026-10-07 Mylan Pharmaceuticals Inc. AMNESTEEM VTRS 2026-10-07 SEAGEN INC. TUKYSA n/a 2026-10-07 STIEFEL DUAC n/a 2026-10-07 Sun Pharmaceutical Industries, Inc. ABSORICA n/a 2026-10-07 Sun Pharmaceutical Industries, Inc. ABSORICA LD n/a 2026-10-07 Teva Pharmaceuticals USA, Inc. CLARAVIS TEVA 2026-10-07 Upsher-Smith Laboratories, LLC ISOTRETINOIN n/a 2026-10-07 Zydus Pharmaceuticals USA Inc. ISOTRETINOIN n/a 2026-10-06 Alvogen, Inc. SERTRALINE HYDROCHLORIDE n/a 2026-10-06 Amneal Pharmaceuticals of New York LLC VALSARTAN AMRX 2026-10-06 Baxter Healthcare Corporation SODIUM BICARBONATE BAX 2026-10-06 Novartis Pharmaceuticals Corporation RHAPSIDO NVS 2026-10-06 SHANDONG SUGAMMADEX SODIUM n/a 2026-10-06 TEVA BRANDED PHARM PROGLYCEM TEVA 2026-10-05 ADAPTIS DOXEPIN HYDROCHLORIDE n/a 2026-10-05 Alembic Pharmaceuticals Limited DIVALPROEX SODIUM n/a 2026-10-05 ALKEM LABS LTD TOPIRAMATE n/a 2026-10-05 Amneal Pharmaceuticals of New York LLC DEXMETHYLPHENIDATE HYDROCHLORIDE AMRX 2026-10-05 ANI PHARMS CORTROPHIN-ZINC ANIP 2026-10-05 ANI PHARMS PURIFIED CORTROPHIN GEL ANIP 2026-10-05 APOTEX CARBAMAZEPINE n/a 2026-10-05 BluePoint Laboratories DICLOFENAC SODIUM n/a 2026-10-05 CROSSMEDIKA SA MOXIFLOXACIN HYDROCHLORIDE n/a 2026-10-05 Golden State Medical Supply, Inc. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE n/a 2026-10-05 Mallinckrodt ARD LLC ACTHAR n/a 2026-10-05 PIRAMAL CRITICAL DESFLURANE n/a 2026-10-05 Torrent Pharmaceuticals Limited CARBAMAZEPINE n/a 2026-10-05 Vitruvias Therapeutics BUPROPION HYDROCHLORIDE (XL) n/a 2026-10-02 Accord Healthcare Inc. CLOZAPINE n/a 2026-10-02 ALVOGEN METHYLPHENIDATE HYDROCHLORIDE n/a 2026-10-02 Amneal Pharmaceuticals LLC EXENATIDE AMRX 2026-10-02 AUROBINDO PHARMA LTD PERAMPANEL n/a 2026-10-02 Baxter Healthcare Corporation FOSAPREPITANT BAX 2026-10-02 COSETTE PHARMS NC DIVALPROEX SODIUM n/a 2026-10-02 Eli Lilly and Company JAYPIRCA LLY 2026-10-02 Haleon US Holdings LLC EXCEDRIN MIGRAINE GELTABS n/a 2026-10-02 HIKMA PHARMS DOXERCALCIFEROL n/a 2026-10-02 Mylan Pharmaceuticals Inc. CLOZAPINE VTRS 2026-10-02 Unichem Pharmaceuticals (USA), Inc. CELECOXIB n/a 2026-10-01 Alembic Pharmaceuticals Limited CARBIDOPA AND LEVODOPA n/a 2026-10-01 ALVOGEN METHYLPHENIDATE HYDROCHLORIDE n/a 2026-10-01 EVER VALINJECT n/a n/a 2026-10-01 Fresenius Kabi USA, LLC FENTANYL CITRATE n/a 2026-10-01 Genentech, Inc. ROZLYTREK RHHBY 2026-10-01 Radha Pharmaceuticals Inc CARBIDOPA AND LEVODOPA n/a 2026-10-01 Sandoz Inc OLANZAPINE SDZNY 2026-09-30 Ajanta Pharma USA Inc. DOXEPIN HYDROCHLORIDE n/a 2026-09-30 Alembic Pharmaceuticals Inc. DOXEPIN HYDROCHLORIDE n/a 2026-09-30 Creekwood Pharmaceuticals LLC ATOMOXETINE n/a 2026-09-30 EPIC PHARMA LLC ACETAZOLAMIDE n/a 2026-09-30 Fresenius Kabi USA, LLC METHOTREXATE n/a 2026-09-30 GLAND LEVOCARNITINE n/a 2026-09-30 H2-Pharma LLC XENICAL n/a 2026-09-30 JAZZ ZEPZELCA JAZZ 2026-09-30 Leadiant Biosciences, Inc. MATULANE n/a 2026-09-30 LUPIN PHYTONADIONE n/a 2026-09-30 MYLAN INDOMETHACIN VTRS 2026-09-30 Myokardia, Inc. CAMZYOS n/a 2026-09-30 NIVAGEN PHARMACEUTICALS, INC. CELECOXIB n/a 2026-09-30 TARO LOPERAMIDE HYDROCHLORIDE n/a 2026-09-29 Amgen, Inc RIABNI AMGN 2026-09-29 Amneal Pharmaceuticals of New York LLC LACOSAMIDE AMRX 2026-09-29 B. Braun Medical Inc. DEXTROSE AND SODIUM CHLORIDE n/a 2026-09-29 CELLTRION INC AVTOZMA n/a 2026-09-29 CELLTRION INC EYDENZELT n/a 2026-09-29 Eugia US LLC AZITHROMYCIN n/a 2026-09-29 Fresenius Kabi USA, LLC RIFAMPIN n/a 2026-09-29 Merck Sharp & Dohme LLC DELSTRIGO MRK 2026-09-29 Merck Sharp & Dohme LLC PIFELTRO MRK 2026-09-29 Sun Pharmaceutical Industries, Inc. FENOFIBRATE n/a 2026-09-29 TEVA PHARMACEUTICALS, INC. PONLIMSI TEVA 2026-09-29 Westminster Pharmaceuticals, LLC CELECOXIB n/a 2026-09-29 XGen Pharmaceuticals DJB, Inc. TRANEXAMIC ACID n/a 2026-09-29 ZYDUS LIFESCIENCES MUPIROCIN CALCIUM n/a 2026-09-28 Accord Healthcare, Inc. METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Agios Pharmaceuticals, Inc. AQVESME AGIO 2026-09-28 Amneal Pharmaceuticals LLC LABETALOL HYDROCHLORIDE AMRX 2026-09-28 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE n/a 2026-09-28 GRANULES METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. TRANEXAMIC ACID HRTG 2026-09-28 Kenvue Brands LLC ZYRTEC n/a 2026-09-28 NEPHRON DEXMEDETOMIDINE HYDROCHLORIDE n/a 2026-09-28 Northstar Rx LLC METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Pfizer Laboratories Div Pfizer Inc RUXIENCE PFE 2026-09-28 PHARMOBEDIENT QUINAPRIL HYDROCHLORIDE n/a 2026-09-28 RARE THYROID THERAPEUTICS INTERNATIONAL AB EMCITATE n/a 2026-09-28 Sandoz Inc BUMETANIDE SDZNY 2026-09-28 TEVA PHARMS DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA 2026-09-28 UPSHER SMITH LABS PREDNISOLONE ACETATE n/a 2026-09-28 Whole Foods Market, Inc. 365 WHOLE FOODS MARKET POLYETHYLENE GLYCOL 3350 n/a Only the 95 most relevant rows are shown. Approved applications (originals and supplements) in this window: 100; rows shown: 95; tickers identified: 29. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...

FDA drug approvals recorded by openFDA between 2026-09-20 and 2026-10-04, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-30 Creekwood Pharmaceuticals LLC ATOMOXETINE n/a 2026-09-30 EPIC PHARMA LLC ACETAZOLAMIDE n/a 2026-09-30 H2-Pharma LLC XENICAL n/a 2026-09-30 JAZZ ZEPZELCA JAZZ 2026-09-30 Myokardia, Inc. CAMZYOS n/a 2026-09-29 Amgen, Inc RIABNI AMGN 2026-09-29 Amneal Pharmaceuticals of New York LLC LACOSAMIDE AMNL 2026-09-29 B. Braun Medical Inc. DEXTROSE AND SODIUM CHLORIDE n/a 2026-09-29 CELLTRION INC EYDENZELT n/a 2026-09-29 CELLTRION USA, Inc. AVTOZMA n/a 2026-09-29 Fresenius Kabi USA, LLC RIFAMPIN n/a 2026-09-29 Merck Sharp & Dohme LLC DELSTRIGO MRK 2026-09-29 Merck Sharp & Dohme LLC PIFELTRO MRK 2026-09-29 XGen Pharmaceuticals DJB, Inc. TRANEXAMIC ACID n/a 2026-09-29 ZYDUS LIFESCIENCES MUPIROCIN CALCIUM n/a 2026-09-28 Accord Healthcare, Inc. METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Agios Pharmaceuticals, Inc. AQVESME AGIO 2026-09-28 Amneal Pharmaceuticals LLC LABETALOL HYDROCHLORIDE AMNL 2026-09-28 Aurobindo Pharma Limited MINOCYCLINE HYDROCHLORIDE n/a 2026-09-28 GRANULES METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Heritage Pharmaceuticals Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc. TRANEXAMIC ACID HRTG 2026-09-28 Kenvue Brands LLC ZYRTEC n/a 2026-09-28 NEPHRON DEXMEDETOMIDINE HYDROCHLORIDE n/a 2026-09-28 Northstar Rx LLC METHYLPHENIDATE HYDROCHLORIDE n/a 2026-09-28 Pfizer Laboratories Div Pfizer Inc RUXIENCE PFE 2026-09-28 PHARMOBEDIENT QUINAPRIL HYDROCHLORIDE n/a 2026-09-28 RARE THYROID THERAPEUTICS INTERNATIONAL AB EMCITATE n/a 2026-09-28 Sandoz Inc BUMETANIDE SDZWF 2026-09-28 TEVA PHARMS DEXMETHYLPHENIDATE HYDROCHLORIDE TEVA 2026-09-28 UPSHER SMITH LABS PREDNISOLONE ACETATE n/a 2026-09-28 Whole Foods Market, Inc. 365 WHOLE FOODS MARKET POLYETHYLENE GLYCOL 3350 n/a 2026-09-25 ADAPTIS KETOROLAC TROMETHAMINE n/a 2026-09-25 ADVENTAPHARMA DWC LLC ZUEINO n/a 2026-09-25 Alvogen Inc. LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-25 AUROBINDO PHARMA LTD METRONIDAZOLE n/a 2026-09-25 Avyxa Pharma, LLC BENDAMUSTINE HYDROCHLORIDE n/a 2026-09-25 AZURITY PHARMACEUTICALS INC n/a n/a 2026-09-25 Bayer HealthCare LLC CLARITIN BAYRY 2026-09-25 Eli Lilly and Company OLUMIANT LLY 2026-09-25 Genentech, Inc. GAZYVA RHHBY 2026-09-25 HERITAGE PHARMS INC DUTASTERIDE n/a 2026-09-25 HONG KONG THIAMINE HYDROCHLORIDE n/a 2026-09-25 INCYTE CORP ATEBRIOZ INCY 2026-09-25 Northstar Rx LLC ATOMOXETINE n/a 2026-09-25 NOVITIUM PHARMA ESOMEPRAZOLE MAGNESIUM n/a 2026-09-25 PLANO PHARMS ARGATROBAN IN SODIUM CHLORIDE n/a 2026-09-25 PURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALS ROSUVASTATIN CALCIUM n/a 2026-09-25 RISING CAPECITABINE n/a 2026-09-25 SANDOZ ROSUVASTATIN CALCIUM SDZWF 2026-09-25 STERISCIENCE NAFCILLIN SODIUM n/a 2026-09-25 Strides Pharma Science Limited ATOMOXETINE n/a 2026-09-25 Sun Pharmaceutical Industries, Inc. FINGOLIMOD n/a 2026-09-25 TEVA PHARMACEUTICALS, INC. DEGEVMA TEVA 2026-09-25 Viona Pharmaceuticals Inc ACYCLOVIR n/a 2026-09-25 WATSON LABS LOSARTAN POTASSIUM n/a 2026-09-25 YICHANG HUMANWELL DILTIAZEM HYDROCHLORIDE n/a 2026-09-24 ACTAVIS LABS FL LINACLOTIDE n/a 2026-09-24 ANI Pharmaceuticals, Inc. RISPERIDONE ANIP 2026-09-24 Baxter Healthcare Corporation DAPZURA RT BAX 2026-09-24 Bionpharma Inc. ATOVAQUONE n/a 2026-09-24 Eisai Inc. LENVIMA n/a 2026-09-24 GRANULES LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-24 Hospira, Inc. BUTORPHANOL TARTRATE n/a 2026-09-24 LANNETT CO INC LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-24 MACLEODS PHARMS CRISABOROLE n/a 2026-09-24 Merck Sharp & Dohme LLC WELIREG MRK 2026-09-24 NEPHRON PHENYLEPHRINE HYDROCHLORIDE n/a 2026-09-24 Roche Laboratories Inc. VALIUM RHHBY 2026-09-24 TEVA PHARMS DORZOLAMIDE HYDROCHLORIDE TEVA 2026-09-23 AIPING PHARM INC GLIPIZIDE n/a 2026-09-23 ANNORA PHARMA NORGESTIMATE AND ETHINYL ESTRADIOL n/a 2026-09-23 APOTEX PAXIL n/a 2026-09-23 Apotex Corp PAROXETINE HYDROCHLORIDE n/a 2026-09-23 ASTRAZENECA CRESTOR AZN 2026-09-23 ELI LILLY AND CO ONSWIK LLY 2026-09-23 HORIZON THERAPEUTICS IRELAND TEPEZZA AMGN 2026-09-23 Mylan Pharmaceuticals Inc. SPIRONOLACTONE VTRS 2026-09-23 SHANDONG KETOROLAC TROMETHAMINE n/a 2026-09-23 STERIMAX CLAFORAN n/a 2026-09-23 United Therapeutics Corporation TYVASO DPI UTHR 2026-09-23 ZYDUS PHARMS MEXILETINE HYDROCHLORIDE n/a 2026-09-22 Accord Healthcare Inc. QUETIAPINE FUMARATE n/a 2026-09-22 Amici Pharma, Inc. RISPERIDONE n/a 2026-09-22 CARMEL BIOSCIENCES PREXXARTAN n/a 2026-09-22 GLENMARK PHARMACEUTICALS INC., USA EPINEPHRINE n/a 2026-09-22 INVAGEN PHARMS EMPAGLIFLOZIN n/a 2026-09-22 IPCA LABS LTD AMLODIPINE BESYLATE n/a 2026-09-22 NOVARTIS SCEMBLIX NVS 2026-09-22 RUBICON RESEARCH PANTOPRAZOLE SODIUM n/a 2026-09-22 SENORES PHARMS HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE n/a 2026-09-21 Aurobindo Pharma Limited VALACYCLOVIR HYDROCHLORIDE n/a 2026-09-21 Breckenridge Pharmaceutical, Inc. DULOXETINE DELAYED-RELEASE n/a 2026-09-21 Dr. Reddy’s Laboratories Ltd DIVALPROEX SODIUM RDY 2026-09-21 LANTHEUS MEDICAL BRAVNETSA LNTH 2026-09-21 MACLEODS PHARMS NEVIRAPINE n/a 2026-09-21 Merck Sharp & Dohme LLC WINREVAIR MRK 2026-09-21 NOVITIUM PHARMA EVEROLIMUS n/a 2026-09-21 Westminster Pharmaceuticals, LLC ACETAZOLAMIDE n/a Only the 98 most relevant rows are shown. Approved applications (originals and supplements) in this window: 100; rows shown: 98; tickers identified: 31. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...

FDA drug approvals recorded by openFDA between 2026-09-13 and 2026-09-27, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-22 Alembic Pharmaceuticals Limited TELMISARTAN AND AMLODIPINE n/a 2026-09-22 Amici Pharma, Inc. RISPERIDONE n/a 2026-09-22 Bayer HealthCare Pharmaceuticals Inc. NUBEQA BAYRY 2026-09-22 Eugia US LLC KETAMINE HYDROCHLORIDE n/a 2026-09-22 GLENMARK PHARMACEUTICALS INC., USA EPINEPHRINE n/a 2026-09-22 Novartis Pharmaceuticals Corporation SCEMBLIX NVS 2026-09-21 Merck Sharp & Dohme LLC WINREVAIR MRK 2026-09-18 AMNEAL LANREOTIDE ACETATE AMNL 2026-09-18 BAXTER HLTHCARE CORP ROCURONIUM BROMIDE BAX 2026-09-18 Eli Lilly and Company INLURIYO LLY 2026-09-18 Eli Lilly and Company VERZENIO LLY 2026-09-18 HIKMA DEFLAZACORT n/a 2026-09-18 INTRABIO AQNEURSA n/a 2026-09-18 Ipsen Biopharmaceuticals, Inc. SOHONOS n/a 2026-09-18 Trifluent Pharma LLC DICLOFENAC POTASSIUM n/a 2026-09-17 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE n/a 2026-09-17 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE n/a 2026-09-17 APOTEX LEVOCETIRIZINE DIHYDROCHLORIDE n/a 2026-09-17 Apotex Corp ICOSAPENT ETHYL n/a 2026-09-17 AUROBINDO PHARMA LTD CYCLOSPORINE n/a 2026-09-17 CIPLA CALCIUM GLUCONATE IN SODIUM CHLORIDE n/a 2026-09-17 FRESENIUS KABI USA DAPTOMYCIN n/a 2026-09-17 JANSSEN PHARMS SPRAVATO JNJ 2026-09-17 LUPIN AMABELZ n/a 2026-09-17 Teva Parenteral Medicines, Inc. PALONOSETRON HYDROCHLORIDE TEVA 2026-09-17 Zydus Pharmaceuticals USA Inc. LACOSAMIDE n/a 2026-09-16 American Health Packaging GABAPENTIN AHR 2026-09-16 ASTRAZENECA TRUQAP AZN 2026-09-16 Aurobindo Pharma Limited MELOXICAM n/a 2026-09-16 Bayer HealthCare Pharmaceuticals Inc. KERENDIA BAYRY 2026-09-16 Chartwell RX, LLC CALCITRIOL n/a 2026-09-16 Fresenius Kabi USA, LLC GLUCAGON n/a 2026-09-16 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. TRANEXAMIC ACID HRTG 2026-09-16 Macleods Pharmaceuticals Limited OLANZAPINE n/a 2026-09-16 Novartis Pharmaceuticals Corporation ZORTRESS NVS 2026-09-16 NUVATION IBTROZI NUVB 2026-09-16 STRIDES PHARMA DEXTROAMPHETAMINE SULFATE n/a 2026-09-16 U.S. Pharmaceuticals XELJANZ n/a 2026-09-16 U.S. Pharmaceuticals XELJANZ XR n/a 2026-09-15 ACTAVIS TOTOWA LETROZOLE n/a 2026-09-15 CHARTWELL RX PRAMIPEXOLE DIHYDROCHLORIDE n/a 2026-09-15 DIFGEN PHARMS EPINEPHRINE n/a 2026-09-15 MACLEODS PHARMS MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 Meitheal Pharmaceuticals Inc. GARZULYS n/a 2026-09-15 Meitheal Pharmaceuticals Inc. TIGECYCLINE n/a 2026-09-15 Mylan Pharmaceuticals Inc. AMNESTEEM VTRS 2026-09-15 Otsuka America Pharmaceutical, Inc. JYNARQUE n/a 2026-09-15 Sandoz Inc TIGECYCLINE SDZWF 2026-09-15 STRIDES PHARMA MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 SUN PHARM INDUSTRIES DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE n/a 2026-09-15 TEVA PHARMS CARBAMAZEPINE TEVA 2026-09-15 Upsher-Smith Laboratories, LLC TESTOSTERONE n/a 2026-09-15 ZYDUS LIFESCIENCES TRETINOIN n/a 2026-09-14 AJANTA PHARMA LTD HALOPERIDOL n/a 2026-09-14 Alembic Pharmaceuticals Inc. ITRACONAZOLE n/a 2026-09-14 ALVOGEN PRIMAQUINE PHOSPHATE n/a 2026-09-14 Amneal Pharmaceuticals LLC ITRACONAZOLE AMNL 2026-09-14 ASTRAZENECA TAGRISSO AZN 2026-09-14 AUROLIFE PHARMA LLC BECLOMETHASONE DIPROPIONATE n/a 2026-09-14 Cranbury Pharmaceuticals, LLC DOXYCYCLINE HYCLATE n/a 2026-09-14 CURIUM BEXLUTRY n/a 2026-09-14 GENENTECH INC EVRYSDI RHHBY 2026-09-14 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. COLISTIMETHATE SODIUM HRTG 2026-09-14 Micro Labs Limited CLOBAZAM n/a 2026-09-14 SAGENT PHARMS INC COLISTIMETHATE SODIUM n/a 2026-09-14 Unichem Pharmaceuticals (USA), Inc. PRIMAQUINE PHOSPHATE n/a 2026-09-14 VistaPharm, LLC METHADONE HYDROCHLORIDE n/a 2026-09-14 Xiromed LLC NEOSTIGMINE METHYLSULFATE n/a 2026-09-14 ZYDUS LIFESCIENCES LETROZOLE n/a 2026-09-14 ZYDUS PHARMS EPINEPHRINE n/a Only the 70 most relevant rows are shown. Approved applications (originals and supplements) in this window: 73; rows shown: 70; tickers identified: 22. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...

FDA drug approvals recorded by openFDA between 2026-09-06 and 2026-09-20, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-18 AMNEAL LANREOTIDE ACETATE AMNL 2026-09-18 BAXTER HLTHCARE CORP ROCURONIUM BROMIDE BAX 2026-09-18 Eli Lilly and Company INLURIYO LLY 2026-09-18 Eli Lilly and Company VERZENIO LLY 2026-09-18 HIKMA DEFLAZACORT n/a 2026-09-18 INTRABIO AQNEURSA n/a 2026-09-18 Ipsen Biopharmaceuticals, Inc. SOHONOS n/a 2026-09-18 Trifluent Pharma LLC DICLOFENAC POTASSIUM n/a 2026-09-17 Actavis Pharma, Inc. DEXTROAMPHETAMINE SULFATE n/a 2026-09-17 Alembic Pharmaceuticals Limited CLONIDINE HYDROCHLORIDE n/a 2026-09-17 APOTEX LEVOCETIRIZINE DIHYDROCHLORIDE n/a 2026-09-17 Apotex Corp ICOSAPENT ETHYL n/a 2026-09-17 AUROBINDO PHARMA LTD CYCLOSPORINE n/a 2026-09-17 CIPLA CALCIUM GLUCONATE IN SODIUM CHLORIDE n/a 2026-09-17 FRESENIUS KABI USA DAPTOMYCIN n/a 2026-09-17 JANSSEN PHARMS SPRAVATO JNJ 2026-09-17 LUPIN AMABELZ n/a 2026-09-17 Teva Parenteral Medicines, Inc. PALONOSETRON HYDROCHLORIDE TEVA 2026-09-17 Zydus Pharmaceuticals USA Inc. LACOSAMIDE n/a 2026-09-16 American Health Packaging GABAPENTIN AHR 2026-09-16 AstraZeneca Pharmaceuticals LP TRUQAP AZN 2026-09-16 Aurobindo Pharma Limited MELOXICAM n/a 2026-09-16 Bayer HealthCare Pharmaceuticals Inc. KERENDIA BAYRY 2026-09-16 Chartwell RX, LLC CALCITRIOL n/a 2026-09-16 Fresenius Kabi USA, LLC GLUCAGON n/a 2026-09-16 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. TRANEXAMIC ACID HRTG 2026-09-16 Macleods Pharmaceuticals Limited OLANZAPINE n/a 2026-09-16 Novartis Pharmaceuticals Corporation ZORTRESS NVS 2026-09-16 NUVATION IBTROZI NUVB 2026-09-16 Pfizer Laboratories Div Pfizer Inc XELJANZ PFE 2026-09-16 Pfizer Laboratories Div Pfizer Inc XELJANZ XR PFE 2026-09-16 STRIDES PHARMA DEXTROAMPHETAMINE SULFATE n/a 2026-09-15 ACTAVIS TOTOWA LETROZOLE n/a 2026-09-15 CHARTWELL RX PRAMIPEXOLE DIHYDROCHLORIDE n/a 2026-09-15 DIFGEN PHARMS EPINEPHRINE n/a 2026-09-15 Eugia US LLC KETAMINE HYDROCHLORIDE n/a 2026-09-15 MACLEODS PHARMS MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 Meitheal Pharmaceuticals Inc. GARZULYS n/a 2026-09-15 Meitheal Pharmaceuticals Inc. TIGECYCLINE n/a 2026-09-15 Mylan Pharmaceuticals Inc. AMNESTEEM VTRS 2026-09-15 Otsuka America Pharmaceutical, Inc. JYNARQUE n/a 2026-09-15 Sandoz Inc TIGECYCLINE SDZWF 2026-09-15 STRIDES PHARMA MILNACIPRAN HYDROCHLORIDE n/a 2026-09-15 SUN PHARM INDUSTRIES DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE n/a 2026-09-15 TEVA PHARMS CARBAMAZEPINE TEVA 2026-09-15 Upsher-Smith Laboratories, LLC TESTOSTERONE n/a 2026-09-15 ZYDUS LIFESCIENCES TRETINOIN n/a 2026-09-14 AJANTA PHARMA LTD HALOPERIDOL n/a 2026-09-14 Alembic Pharmaceuticals Inc. ITRACONAZOLE n/a 2026-09-14 ALVOGEN PRIMAQUINE PHOSPHATE n/a 2026-09-14 Amneal Pharmaceuticals LLC ITRACONAZOLE AMNL 2026-09-14 ASTRAZENECA TAGRISSO AZN 2026-09-14 AUROLIFE PHARMA LLC BECLOMETHASONE DIPROPIONATE n/a 2026-09-14 Cranbury Pharmaceuticals, LLC DOXYCYCLINE HYCLATE n/a 2026-09-14 CURIUM BEXLUTRY n/a 2026-09-14 Genentech, Inc. EVRYSDI RHHBY 2026-09-14 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. COLISTIMETHATE SODIUM HRTG 2026-09-14 Micro Labs Limited CLOBAZAM n/a 2026-09-14 SAGENT PHARMS INC COLISTIMETHATE SODIUM n/a 2026-09-14 Unichem Pharmaceuticals (USA), Inc. PRIMAQUINE PHOSPHATE n/a 2026-09-14 VistaPharm, LLC METHADONE HYDROCHLORIDE n/a 2026-09-14 Xiromed LLC NEOSTIGMINE METHYLSULFATE n/a 2026-09-14 ZYDUS LIFESCIENCES LETROZOLE n/a 2026-09-14 ZYDUS PHARMS EPINEPHRINE n/a 2026-09-11 Amgen, Inc IMDELLTRA (AMG757) AMGN 2026-09-11 APOTEX ITRACONAZOLE n/a 2026-09-11 Chartwell Governmental & Specialty RX, LLC. ETHOSUXIMIDE n/a 2026-09-11 Exelan Pharmaceuticals, Inc. GABAPENTIN n/a 2026-09-11 Kythera Biopharmaceuticals Inc. KYBELLA n/a 2026-09-11 MSN DASATINIB n/a 2026-09-11 Pharming Healthcare Inc. JOENJA PHAR 2026-09-11 RICONPHARMA LLC SIPONIMOD n/a 2026-09-11 RISING PENTOSTATIN n/a 2026-09-11 SCHOLAR ROCK INC ISEMBYLD SRRK 2026-09-11 SpecGx LLC MORPHINE SULFATE n/a 2026-09-11 Sun Pharmaceutical Industries, Inc. CARBIDOPA AND LEVODOPA n/a 2026-09-11 TELIX PHARMACEUTICALS US INC PIXCLARA TLX 2026-09-11 Teva Parenteral Medicines, Inc. PACLITAXEL TEVA 2026-09-11 Teva Pharmaceuticals USA, Inc. CARBIDOPA AND LEVODOPA TEVA 2026-09-11 The Fresh Test, LLC POLYETHYLENE GLYCOL 3350 n/a 2026-09-10 Alembic Pharmaceuticals Limited ASENAPINE n/a 2026-09-10 AUROBINDO PHARMA LTD ISOTRETINOIN n/a 2026-09-10 Camber Pharmaceuticals, Inc. LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-10 Granules Pharmaceuticals Inc. LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-10 HIKMA HYDROMORPHONE HYDROCHLORIDE n/a 2026-09-10 Hikma Pharmaceuticals USA Inc. HYDROMORPHONE HYDROCHLORIDE n/a 2026-09-10 MAYNE PHARMA ANNOVERA n/a 2026-09-10 RUBICON RESEARCH SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE n/a 2026-09-10 Solco Healthcare US,LLC LISDEXAMFETAMINE DIMESYLATE n/a 2026-09-09 Alembic Pharmaceuticals Limited ROPINIROLE n/a 2026-09-09 BAYER HEALTHCARE HYRNUO BAYRY 2026-09-09 BIOFRONTERA AMELUZ n/a 2026-09-08 HETERO LABS LTD V IBRUTINIB n/a 2026-09-08 Saptalis Pharmaceuticals, LLC. TRIAMCINOLONE ACETONIDE n/a 2026-09-08 ZHEJIANG JUTAI PHARM BRIVARACETAM n/a Only the 95 most relevant rows are shown. Approved applications (originals and supplements) in this window: 100; rows shown: 95; tickers identified: 28. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...

FDA drug approvals recorded by openFDA between 2026-08-30 and 2026-09-13, newest first. Company is the first listed manufacturer; tickers link to Seeking Alpha. Approval Date Company Drug Ticker 2026-09-09 Bayer HealthCare Pharmaceuticals Inc. HYRNUO BAYRY 2026-09-09 Biofrontera Inc. AMELUZ n/a 2026-09-08 HETERO LABS LTD V IBRUTINIB n/a 2026-09-08 Saptalis Pharmaceuticals, LLC. TRIAMCINOLONE ACETONIDE n/a 2026-09-08 ZHEJIANG JUTAI PHARM BRIVARACETAM n/a 2026-09-04 ACTAVIS ELIZABETH DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE n/a 2026-09-04 AstraZeneca Pharmaceuticals LP ETCAMAH AZN 2026-09-04 Clarity Cosmetics Inc. MINOXIDIL n/a 2026-09-04 MICRO LABS TOPIRAMATE AMD 2026-09-04 NorthStar Rx LLC NITROFURANTOIN n/a 2026-09-04 Tris Pharma Inc LACOSAMIDE n/a 2026-09-03 BPI LABS TESTOSTERONE CYPIONATE n/a 2026-09-03 HANDA ONCOLOGY, LLC n/a n/a 2026-09-03 Horizon Therapeutics USA, Inc. UPLIZNA AMGN 2026-09-03 IONIS PHARMS INC ZANVASTRO IONS 2026-09-03 LUPIN MODAFINIL n/a 2026-09-03 Modavar Pharmaceuticals LLC ACYCLOVIR n/a 2026-09-03 Novadoz Pharmaceuticals LLC TAPENTADOL HYDROCHLORIDE n/a 2026-09-02 Aadi Bioscience, Inc. FYARRO n/a 2026-09-02 Actavis Pharma, Inc. BUPROPION HYDROCHLORIDE SR n/a 2026-09-02 Ajanta Pharma USA Inc. DAPAGLIFLOZIN n/a 2026-09-02 AUROBINDO PHARMA LTD SACUBITRIL AND VALSARTAN n/a 2026-09-02 Celgene Corporation THALOMID n/a 2026-09-02 CELLTRION USA, Inc. AVTOZMA n/a 2026-09-02 H2-Pharma, LLC ETOPOPHOS n/a 2026-09-02 NATCO THALIDOMIDE n/a 2026-09-02 PHARMOBEDIENT DIVALPROEX SODIUM n/a 2026-09-02 PRECISION DOSE INC ALENDRONATE SODIUM n/a 2026-09-02 SUN PHARM INDS LTD OXCARBAZEPINE n/a 2026-09-02 U.S. Pharmaceuticals CIBINQO n/a 2026-09-01 B. Braun Medical Inc. LIDOCAINE HCL AND EPINEPHRINE n/a 2026-09-01 BIOGEN INC. BYOOVIZ BIIB 2026-09-01 Chartwell RX, LLC ULTRAMICROSIZE GRISEOFULVIN n/a 2026-09-01 Leading Pharma, LLC DOXEPIN HYDROCHLORIDE n/a 2026-09-01 Meitheal Pharmaceuticals Inc NELARABINE n/a 2026-09-01 Mirati Therapeutics, Inc KRAZATI BMY 2026-09-01 Mylan Pharmaceuticals Inc. NEVIRAPINE VTRS 2026-09-01 Pharmacia & Upjohn Company LLC CLEOCIN HYDROCHLORIDE VTRS 2026-08-31 Akeso Biopharma, Co., Ltd PENPULIMAB KCQX n/a 2026-08-31 AstraZeneca Pharmaceuticals LP IMFINZI AZN 2026-08-31 AstraZeneca Pharmaceuticals LP IMJUDO AZN 2026-08-31 Aurohealth LLC FEXOFENADINE HYDROCHLORIDE n/a 2026-08-31 Baxter Healthcare Corporation CEFAZOLIN BAX 2026-08-31 Baxter Healthcare Corporation OXACILLIN BAX 2026-08-31 Chattem, Inc. CHILDRENS XYZAL ALLERGY n/a 2026-08-31 Cipla USA Inc. POMALIDOMIDE n/a 2026-08-31 Coherus Oncology, Inc. LOQTORZI CHRS 2026-08-31 Dr. Reddy’s Laboratories Inc. POMALIDOMIDE RDY 2026-08-31 E.R. Squibb & Sons, L.L.C. YERVOY BMY 2026-08-31 EMD Serono, Inc. BAVENCIO MKKGY 2026-08-31 Leading Pharma, LLC FENOFIBRIC ACID n/a 2026-08-31 Lupin Pharmaceuticals, Inc. MEFENAMIC ACID n/a 2026-08-31 MACLEODS PHARMS LTD SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE n/a 2026-08-31 Micro Labs Limited MEFENAMIC ACID AMD 2026-08-31 Micro Labs Limited TRANEXAMIC ACID AMD 2026-08-31 PETNET Solutions, Inc. FLUDEOXYGLUCOSE F 18 n/a 2026-08-31 QILU PHARM HAINAN DIFELIKEFALIN ACETATE n/a 2026-08-31 Regeneron Pharmaceuticals, Inc. LIBTAYO REGN 2026-08-31 SANDOZ EPLERENONE SDZWF 2026-08-31 SANDOZ TERIFLUNOMIDE SDZWF 2026-08-31 Sandoz Inc POMALIDOMIDE SDZWF 2026-08-31 Sun Pharmaceutical Industries, Inc. POMALIDOMIDE n/a 2026-08-31 Sun Pharmaceutical Industries, Inc. UNLOXCYT n/a Only the 63 most relevant rows are shown. Approved applications (originals and supplements) in this window: 64; rows shown: 63; tickers identified: 23. Known pharma subsidiaries are mapped to their US-listed parent or ADR (e.g. Janssen -> JNJ, Novartis -> NVS). Companies shown as “n/a” are mostly foreign or privately held drug makers (mostly generics) with no US-listed stock. ...