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 DateCompanyDrugTicker
2026-09-18AMNEALLANREOTIDE ACETATEAMNL
2026-09-18BAXTER HLTHCARE CORPROCURONIUM BROMIDEBAX
2026-09-18Eli Lilly and CompanyINLURIYOLLY
2026-09-18Eli Lilly and CompanyVERZENIOLLY
2026-09-18HIKMADEFLAZACORTn/a
2026-09-18INTRABIOAQNEURSAn/a
2026-09-18Ipsen Biopharmaceuticals, Inc.SOHONOSn/a
2026-09-18Trifluent Pharma LLCDICLOFENAC POTASSIUMn/a
2026-09-17Actavis Pharma, Inc.DEXTROAMPHETAMINE SULFATEn/a
2026-09-17Alembic Pharmaceuticals LimitedCLONIDINE HYDROCHLORIDEn/a
2026-09-17APOTEXLEVOCETIRIZINE DIHYDROCHLORIDEn/a
2026-09-17Apotex CorpICOSAPENT ETHYLn/a
2026-09-17AUROBINDO PHARMA LTDCYCLOSPORINEn/a
2026-09-17CIPLACALCIUM GLUCONATE IN SODIUM CHLORIDEn/a
2026-09-17FRESENIUS KABI USADAPTOMYCINn/a
2026-09-17JANSSEN PHARMSSPRAVATOJNJ
2026-09-17LUPINAMABELZn/a
2026-09-17Teva Parenteral Medicines, Inc.PALONOSETRON HYDROCHLORIDETEVA
2026-09-17Zydus Pharmaceuticals USA Inc.LACOSAMIDEn/a
2026-09-16American Health PackagingGABAPENTINAHR
2026-09-16AstraZeneca Pharmaceuticals LPTRUQAPAZN
2026-09-16Aurobindo Pharma LimitedMELOXICAMn/a
2026-09-16Bayer HealthCare Pharmaceuticals Inc.KERENDIABAYRY
2026-09-16Chartwell RX, LLCCALCITRIOLn/a
2026-09-16Fresenius Kabi USA, LLCGLUCAGONn/a
2026-09-16Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.TRANEXAMIC ACIDHRTG
2026-09-16Macleods Pharmaceuticals LimitedOLANZAPINEn/a
2026-09-16Novartis Pharmaceuticals CorporationZORTRESSNVS
2026-09-16NUVATIONIBTROZINUVB
2026-09-16Pfizer Laboratories Div Pfizer IncXELJANZPFE
2026-09-16Pfizer Laboratories Div Pfizer IncXELJANZ XRPFE
2026-09-16STRIDES PHARMADEXTROAMPHETAMINE SULFATEn/a
2026-09-15ACTAVIS TOTOWALETROZOLEn/a
2026-09-15CHARTWELL RXPRAMIPEXOLE DIHYDROCHLORIDEn/a
2026-09-15DIFGEN PHARMSEPINEPHRINEn/a
2026-09-15Eugia US LLCKETAMINE HYDROCHLORIDEn/a
2026-09-15MACLEODS PHARMSMILNACIPRAN HYDROCHLORIDEn/a
2026-09-15Meitheal Pharmaceuticals Inc.GARZULYSn/a
2026-09-15Meitheal Pharmaceuticals Inc.TIGECYCLINEn/a
2026-09-15Mylan Pharmaceuticals Inc.AMNESTEEMVTRS
2026-09-15Otsuka America Pharmaceutical, Inc.JYNARQUEn/a
2026-09-15Sandoz IncTIGECYCLINESDZWF
2026-09-15STRIDES PHARMAMILNACIPRAN HYDROCHLORIDEn/a
2026-09-15SUN PHARM INDUSTRIESDEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEn/a
2026-09-15TEVA PHARMSCARBAMAZEPINETEVA
2026-09-15Upsher-Smith Laboratories, LLCTESTOSTERONEn/a
2026-09-15ZYDUS LIFESCIENCESTRETINOINn/a
2026-09-14AJANTA PHARMA LTDHALOPERIDOLn/a
2026-09-14Alembic Pharmaceuticals Inc.ITRACONAZOLEn/a
2026-09-14ALVOGENPRIMAQUINE PHOSPHATEn/a
2026-09-14Amneal Pharmaceuticals LLCITRACONAZOLEAMNL
2026-09-14ASTRAZENECATAGRISSOAZN
2026-09-14AUROLIFE PHARMA LLCBECLOMETHASONE DIPROPIONATEn/a
2026-09-14Cranbury Pharmaceuticals, LLCDOXYCYCLINE HYCLATEn/a
2026-09-14CURIUMBEXLUTRYn/a
2026-09-14Genentech, Inc.EVRYSDIRHHBY
2026-09-14Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.COLISTIMETHATE SODIUMHRTG
2026-09-14Micro Labs LimitedCLOBAZAMn/a
2026-09-14SAGENT PHARMS INCCOLISTIMETHATE SODIUMn/a
2026-09-14Unichem Pharmaceuticals (USA), Inc.PRIMAQUINE PHOSPHATEn/a
2026-09-14VistaPharm, LLCMETHADONE HYDROCHLORIDEn/a
2026-09-14Xiromed LLCNEOSTIGMINE METHYLSULFATEn/a
2026-09-14ZYDUS LIFESCIENCESLETROZOLEn/a
2026-09-14ZYDUS PHARMSEPINEPHRINEn/a
2026-09-11Amgen, IncIMDELLTRA (AMG757)AMGN
2026-09-11APOTEXITRACONAZOLEn/a
2026-09-11Chartwell Governmental & Specialty RX, LLC.ETHOSUXIMIDEn/a
2026-09-11Exelan Pharmaceuticals, Inc.GABAPENTINn/a
2026-09-11Kythera Biopharmaceuticals Inc.KYBELLAn/a
2026-09-11MSNDASATINIBn/a
2026-09-11Pharming Healthcare Inc.JOENJAPHAR
2026-09-11RICONPHARMA LLCSIPONIMODn/a
2026-09-11RISINGPENTOSTATINn/a
2026-09-11SCHOLAR ROCK INCISEMBYLDSRRK
2026-09-11SpecGx LLCMORPHINE SULFATEn/a
2026-09-11Sun Pharmaceutical Industries, Inc.CARBIDOPA AND LEVODOPAn/a
2026-09-11TELIX PHARMACEUTICALS US INCPIXCLARATLX
2026-09-11Teva Parenteral Medicines, Inc.PACLITAXELTEVA
2026-09-11Teva Pharmaceuticals USA, Inc.CARBIDOPA AND LEVODOPATEVA
2026-09-11The Fresh Test, LLCPOLYETHYLENE GLYCOL 3350n/a
2026-09-10Alembic Pharmaceuticals LimitedASENAPINEn/a
2026-09-10AUROBINDO PHARMA LTDISOTRETINOINn/a
2026-09-10Camber Pharmaceuticals, Inc.LISDEXAMFETAMINE DIMESYLATEn/a
2026-09-10Granules Pharmaceuticals Inc.LISDEXAMFETAMINE DIMESYLATEn/a
2026-09-10HIKMAHYDROMORPHONE HYDROCHLORIDEn/a
2026-09-10Hikma Pharmaceuticals USA Inc.HYDROMORPHONE HYDROCHLORIDEn/a
2026-09-10MAYNE PHARMAANNOVERAn/a
2026-09-10RUBICON RESEARCHSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEn/a
2026-09-10Solco Healthcare US,LLCLISDEXAMFETAMINE DIMESYLATEn/a
2026-09-09Alembic Pharmaceuticals LimitedROPINIROLEn/a
2026-09-09BAYER HEALTHCAREHYRNUOBAYRY
2026-09-09BIOFRONTERAAMELUZn/a
2026-09-08HETERO LABS LTD VIBRUTINIBn/a
2026-09-08Saptalis Pharmaceuticals, LLC.TRIAMCINOLONE ACETONIDEn/a
2026-09-08ZHEJIANG JUTAI PHARMBRIVARACETAMn/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.


Data source: openFDA