← Every applicant
Hetero Labs Ltd V FDA Approvals
51 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 |
|---|
| IBRUTINIBNew drugSep 8, 2026CAPSULE, ORAL |
| AFATINIB DIMALEATENew drugJul 14, 2026TABLET, ORAL |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENew drugMay 27, 2026TABLET, ORAL |
| NILOTINIB HYDROCHLORIDENew drugNov 19, 2025CAPSULE, ORAL |
| OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDENew drugOct 6, 2025TABLET, ORAL |
| VORICONAZOLENew drugAug 8, 2025FOR SUSPENSION, ORAL |
| OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENew drugJul 25, 2025TABLET, ORAL |
| ABACAVIR SULFATE AND LAMIVUDINENew drugApr 16, 2025TABLET, ORAL |
| IMATINIB MESYLATENew drugApr 14, 2025TABLET, ORAL |
| AMLODIPINE AND OLMESARTAN MEDOXOMILNew drugFeb 14, 2025TABLET, ORAL |
| ELTROMBOPAG OLAMINENew drugJan 17, 2025TABLET, ORAL |
| OLMESARTAN MEDOXOMILNew drugOct 31, 2024TABLET, ORAL |
| MYCOPHENOLATE MOFETILNew drugOct 22, 2024CAPSULE, ORAL |
| MYCOPHENOLATE MOFETILNew drugOct 22, 2024TABLET, ORAL |
| MILNACIPRAN HYDROCHLORIDENew drugOct 3, 2024TABLET, ORAL |
| POMALIDOMIDENew drugSep 26, 2024CAPSULE, ORAL |
| ERTUGLIFLOZINNew drugSep 17, 2024TABLET, ORAL |
| SIROLIMUSNew drugSep 16, 2024SOLUTION, ORAL |
| TEMOZOLOMIDENew drugAug 23, 2024CAPSULE, ORAL |
| AVANAFILNew drugJun 14, 2024TABLET, ORAL |
| ERLOTINIB HYDROCHLORIDENew drugMay 24, 2024TABLET, ORAL |
| PITAVASTATIN CALCIUMNew drugApr 30, 2024TABLET, ORAL |
| CAPECITABINENew drugMar 5, 2024TABLET, ORAL |
| OSPEMIFENENew drugFeb 13, 2024TABLET, ORAL |
| FESOTERODINE FUMARATENew drugJan 9, 2024TABLET, EXTENDED RELEASE, ORAL |
| ESZOPICLONENew drugJan 4, 2024TABLET, ORAL |
| APIXABANNew drugNov 21, 2023TABLET, ORAL |
| BREXPIPRAZOLENew drugNov 20, 2023TABLET, ORAL |
| ATORVASTATIN CALCIUMNew drugSep 12, 2023TABLET, ORAL |
| CLOPIDOGREL BISULFATENew drugAug 4, 2023TABLET, ORAL |
| ALLOPURINOLNew drugAug 3, 2023TABLET, ORAL |
| ESLICARBAZEPINE ACETATENew drugAug 3, 2023TABLET, ORAL |
| LORATADINENew drugJul 28, 2023TABLET, ORAL |
| LENALIDOMIDENew drugMay 11, 2023CAPSULE, ORAL |
| TERIFLUNOMIDENew drugMar 13, 2023TABLET, ORAL |
| MOXIFLOXACIN HYDROCHLORIDENew drugMar 2, 2023TABLET, ORAL |
| NAPROXEN SODIUMNew drugOct 28, 2022TABLET, ORAL |
| VALGANCICLOVIR HYDROCHLORIDENew drugOct 4, 2022FOR SOLUTION, ORAL |
| MEMANTINE HYDROCHLORIDENew drugSep 26, 2022TABLET, ORAL |
| PIRFENIDONENew drugSep 21, 2022TABLET, ORAL |
| SODIUM PICOSULFATE, MAGNESIUM OXIDE AND ANHYDROUS CITRIC ACIDNew drugJul 18, 2022FOR SOLUTION, ORAL |
| QUETIAPINE FUMARATENew drugJun 16, 2022TABLET, ORAL |
| OSELTAMIVIR PHOSPHATENew drugMar 28, 2022FOR SUSPENSION, ORAL |
| LACOSAMIDENew drugMar 17, 2022TABLET, ORAL |
| EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATENew drugJan 24, 2022TABLET, ORAL |
| COLCHICINENew drugAug 13, 2021TABLET, ORAL |
| TOLTERODINE TARTRATENew drugAug 2, 2021TABLET, ORAL |
| TOLVAPTANNew drugJul 16, 2021TABLET, ORAL |
| LOPERAMIDE HYDROCHLORIDE AND SIMETHICONENew drugJun 17, 2021TABLET, ORAL |
| SILDENAFIL CITRATENew drugMay 11, 2021FOR SUSPENSION, ORAL |
| ATOMOXETINE HYDROCHLORIDENew drugMar 11, 2021CAPSULE, ORAL |