← Every applicant
Hetero Labs Ltd Iii FDA Approvals
26 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 |
|---|
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDENew drugMar 12, 2026SYRUP, ORAL |
| FLUPHENAZINE HYDROCHLORIDENew drugNov 18, 2025TABLET, ORAL |
| SACUBITRIL AND VALSARTANNew drugJul 17, 2025TABLET, ORAL |
| SPIRONOLACTONENew drugFeb 21, 2025SUSPENSION, ORAL |
| RALTEGRAVIR POTASSIUMNew drugDec 19, 2024TABLET, ORAL |
| DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATENew drugAug 28, 2024CAPSULE, ORAL |
| RUFINAMIDENew drugDec 5, 2023SUSPENSION, ORAL |
| ARIPIPRAZOLENew drugNov 1, 2023SOLUTION, ORAL |
| VARENICLINE TARTRATENew drugOct 23, 2023TABLET, ORAL |
| OXCARBAZEPINENew drugOct 20, 2023SUSPENSION, ORAL |
| LAMIVUDINENew drugOct 6, 2023SOLUTION, ORAL |
| DARUNAVIRNew drugSep 14, 2023TABLET, ORAL |
| POSACONAZOLENew drugDec 8, 2022TABLET, DELAYED RELEASE, ORAL |
| KETOROLAC TROMETHAMINENew drugAug 25, 2022TABLET, ORAL |
| EZETIMIBENew drugJul 26, 2022TABLET, ORAL |
| ACYCLOVIRNew drugJul 1, 2022SUSPENSION, ORAL |
| TRIENTINE HYDROCHLORIDENew drugJun 23, 2022CAPSULE, ORAL |
| NAPROXENNew drugJun 7, 2022SUSPENSION, ORAL |
| LACOSAMIDENew drugMay 31, 2022SOLUTION, ORAL |
| RANOLAZINENew drugMay 5, 2022TABLET, EXTENDED RELEASE, ORAL |
| MARAVIROCNew drugFeb 7, 2022TABLET, ORAL |
| ATAZANAVIR SULFATENew drugFeb 2, 2022CAPSULE, ORAL |
| EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENew drugOct 7, 2021TABLET, ORAL |
| LOPINAVIR AND RITONAVIRNew drugJun 4, 2021TABLET, ORAL |
| RUFINAMIDENew drugMay 11, 2021TABLET, ORAL |
| LORATADINENew drugMay 7, 2021SYRUP, ORAL |