← Every applicant
Apotex FDA Approvals
94 new drug approvals and 0 device clearances on file. This applicant is not matched to a listed company.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| AFATINIB DIMALEATENew drugJul 14, 2026TABLET, ORAL |
| POSACONAZOLENew drugJun 29, 2026TABLET, DELAYED RELEASE, ORAL |
| TOFACITINIB CITRATENew drugJun 3, 2026TABLET, EXTENDED RELEASE, ORAL |
| TOFACITINIB CITRATENew drugJun 3, 2026TABLET, ORAL |
| EVEROLIMUSNew drugMay 12, 2026TABLET, ORAL |
| EVDINew drugMay 1, 2026SOLUTION, INTRAVENOUS |
| SITAGLIPTIN AND METFORMIN HYDROCHLORIDENew drugApr 30, 2026TABLET, ORAL |
| MULTIPLE VITAMINS INJECTION PEDIATRICNew drugApr 21, 2026INJECTABLE, INTRAVENOUS |
| MULTIPLE VITAMINS INJECTION PEDIATRIC (PHARMACY BULK PACKAGE)New drugApr 21, 2026INJECTABLE, INTRAVENOUS |
| CANAGLIFLOZINNew drugApr 14, 2026TABLET, ORAL |
| MULTIPLE VITAMINS INJECTION ADULTNew drugApr 9, 2026SOLUTION, INTRAVENOUS |
| MULTIPLE VITAMINS INJECTION ADULTNew drugApr 9, 2026SOLUTION, INTRAVENOUS |
| NINTEDANIB ESYLATENew drugApr 2, 2026CAPSULE, ORAL |
| RIVAROXABANNew drugMar 2, 2026FOR SUSPENSION, ORAL |
| BRIVARACETAMNew drugFeb 23, 2026TABLET, ORAL |
| HYDROCORTISONE SODIUM SUCCINATENew drugFeb 5, 2026INJECTABLE, INJECTION |
| FIDAXOMICINNew drugFeb 2, 2026TABLET, ORAL |
| EMTRICITABINE, RILPIVIRINE, AND TENOFOVIR ALAFENAMIDENew drugJan 30, 2026TABLET, ORAL |
| PALIPERIDONENew drugJan 26, 2026TABLET, EXTENDED RELEASE, ORAL |
| SITAGLIPTIN PHOSPHATENew drugJan 20, 2026TABLET, ORAL |
| CLADRIBINENew drugNov 24, 2025TABLET, ORAL |
| RIVAROXABANNew drugNov 14, 2025TABLET, ORAL |
| TOLVAPTANNew drugNov 10, 2025TABLET, ORAL |
| AXITINIBNew drugOct 30, 2025TABLET, ORAL |
| PRUCALOPRIDE SUCCINATENew drugJun 24, 2025TABLET, ORAL |
| RIVAROXABANNew drugMay 2, 2025TABLET, ORAL |
| TICAGRELORNew drugMay 1, 2025TABLET, ORAL |
| BREXPIPRAZOLENew drugFeb 24, 2025TABLET, ORAL |
| SORAFENIB TOSYLATENew drugJan 27, 2025TABLET, ORAL |
| MIRABEGRONNew drugJan 2, 2025TABLET, EXTENDED RELEASE, ORAL |
| DOXYCYCLINENew drugJul 11, 2024CAPSULE, ORAL |
| ELIGLUSTAT TARTRATENew drugJul 10, 2024CAPSULE, ORAL |
| BROMFENAC SODIUMNew drugJul 8, 2024SOLUTION/DROPS, OPHTHALMIC |
| POMALIDOMIDENew drugJun 11, 2024CAPSULE, ORAL |
| ZINC SULFATENew drugJun 10, 2024SOLUTION, INTRAVENOUS |
| LOSARTAN POTASSIUMNew drugJun 4, 2024TABLET, ORAL |
| AZELASTINE HYDROCHLORIDE CHILDREN'S ALLERGYNew drugMay 29, 2024SPRAY, METERED, NASAL |
| EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATENew drugMay 17, 2024TABLET, ORAL |
| MOMETASONE FUROATENew drugApr 23, 2024SPRAY, METERED, NASAL |
| TENOFOVIR ALAFENAMIDE FUMARATENew drugMar 21, 2024TABLET, ORAL |
| CARBAMAZEPINENew drugMar 8, 2024TABLET, EXTENDED RELEASE, ORAL |
| NEBIVOLOL HYDROCHLORIDENew drugFeb 27, 2024TABLET, ORAL |
| APIXABANNew drugFeb 16, 2024TABLET, ORAL |
| MACITENTANNew drugJan 9, 2024TABLET, ORAL |
| NILOTINIB HYDROCHLORIDENew drugJan 5, 2024CAPSULE, ORAL |
| DABIGATRAN ETEXILATE MESYLATENew drugDec 15, 2023CAPSULE, ORAL |
| ESLICARBAZEPINE ACETATENew drugDec 7, 2023TABLET, ORAL |
| TERIPARATIDENew drugNov 16, 2023SOLUTION, SUBCUTANEOUS |
| LACOSAMIDENew drugNov 13, 2023SOLUTION, INTRAVENOUS |
| PAZOPANIB HYDROCHLORIDENew drugOct 19, 2023TABLET, ORAL |
| LISDEXAMFETAMINE DIMESYLATENew drugAug 25, 2023CAPSULE, ORAL |
| DEXAMETHASONENew drugAug 23, 2023TABLET, ORAL |
| IVRANew drugAug 18, 2023SOLUTION, INTRAVENOUS |
| PONATINIB HYDROCHLORIDENew drugJul 14, 2023TABLET, ORAL |
| OXCARBAZEPINENew drugJul 13, 2023TABLET, EXTENDED RELEASE, ORAL |
| VILAZODONE HYDROCHLORIDENew drugJul 7, 2023TABLET, ORAL |
| PIRFENIDONENew drugJun 9, 2023CAPSULE, ORAL |
| BENDAMUSTINE HYDROCHLORIDENew drugJun 5, 2023POWDER, INTRAVENOUS |
| PIRFENIDONENew drugMay 31, 2023TABLET, ORAL |
| OBETICHOLIC ACIDNew drugMay 30, 2023TABLET, ORAL |
| ACETAMINOPHENNew drugApr 18, 2023SOLUTION, INTRAVENOUS |
| CABAZITAXELNew drugFeb 10, 2023SOLUTION, INTRAVENOUS |
| VARENICLINE TARTRATENew drugJan 25, 2023TABLET, ORAL |
| TRIAMCINOLONE ACETONIDENew drugJan 19, 2023SPRAY, METERED, NASAL |
| CYCLOSPORINENew drugJan 12, 2023EMULSION, OPHTHALMIC |
| BRIMONIDINE TARTRATENew drugDec 21, 2022SOLUTION/DROPS, OPHTHALMIC |
| TASIMELTEONNew drugDec 20, 2022CAPSULE, ORAL |
| BENDAMUSTINE HYDROCHLORIDENew drugDec 7, 2022SOLUTION, INTRAVENOUS |
| LACOSAMIDENew drugSep 26, 2022SOLUTION, ORAL |
| LACOSAMIDENew drugSep 23, 2022TABLET, ORAL |
| GEFITINIBNew drugSep 23, 2022TABLET, ORAL |
| LENALIDOMIDENew drugAug 30, 2022CAPSULE, ORAL |
| FLUPHENAZINE HYDROCHLORIDENew drugJul 15, 2022TABLET, ORAL |
| PEMETREXED DISODIUMNew drugMay 25, 2022POWDER, INTRAVENOUS |
| PEMETREXED DISODIUMNew drugMay 25, 2022POWDER, INTRAVENOUS |
| PEMETREXED DISODIUMNew drugMay 25, 2022POWDER, INTRAVENOUS |
| AMBRISENTANNew drugMay 19, 2022TABLET, ORAL |
| DICLOFENAC SODIUMNew drugMay 6, 2022SOLUTION, TOPICAL |
| BORTEZOMIBNew drugMay 2, 2022INJECTABLE, INTRAVENOUS, SUBCUTANEOUS |
| ENZALUTAMIDENew drugApr 22, 2022CAPSULE, ORAL |
| BRIMONIDINE TARTRATE AND TIMOLOL MALEATENew drugApr 20, 2022SOLUTION/DROPS, OPHTHALMIC |
| REGADENOSONNew drugApr 11, 2022SOLUTION, INTRAVENOUS |
| BRIMONIDINE TARTRATENew drugJan 31, 2022SOLUTION/DROPS, OPHTHALMIC |
| METFORMIN HYDROCHLORIDENew drugDec 13, 2021TABLET, EXTENDED RELEASE, ORAL |
| ATROPINE SULFATENew drugNov 26, 2021SOLUTION/DROPS, OPHTHALMIC |
| DASATINIBNew drugNov 23, 2021TABLET, ORAL |
| CEFTAROLINE FOSAMILNew drugSep 21, 2021POWDER, INTRAVENOUS |
| ATORVASTATIN CALCIUMNew drugSep 2, 2021TABLET, ORAL |
| PREGABALINNew drugJul 7, 2021CAPSULE, ORAL |
| ICOSAPENT ETHYLNew drugJun 30, 2021CAPSULE, ORAL |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENew drugJun 16, 2021TABLET, ORAL |
| FULVESTRANTNew drugJun 11, 2021SOLUTION, INTRAMUSCULAR |
| LEVOCETIRIZINE DIHYDROCHLORIDENew drugApr 21, 2021TABLET, ORAL |
| PREGABALINNew drugApr 13, 2021TABLET, EXTENDED RELEASE, ORAL |