← Every applicant
Novitium Pharma FDA Approvals
65 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 |
|---|
| ESOMEPRAZOLE MAGNESIUMNew drugSep 25, 2026FOR SUSPENSION, DELAYED RELEASE, ORAL |
| EVEROLIMUSNew drugSep 21, 2026TABLET, FOR SUSPENSION, ORAL |
| FOSFOMYCIN TROMETHAMINENew drugAug 12, 2026FOR SOLUTION, ORAL |
| PITOLISANT HYDROCHLORIDENew drugJul 21, 2026TABLET, ORAL |
| RIFAMPINNew drugJun 29, 2026CAPSULE, ORAL |
| TRAMADOL HYDROCHLORIDENew drugJun 26, 2026SOLUTION, ORAL |
| PIMOZIDENew drugApr 13, 2026TABLET, ORAL |
| MIRTAZAPINENew drugFeb 2, 2026TABLET, ORAL |
| TAPENTADOL HYDROCHLORIDENew drugJan 26, 2026SOLUTION, ORAL |
| SERTRALINE HYDROCHLORIDENew drugJan 20, 2026CAPSULE, ORAL |
| HYDROXYZINE HYDROCHLORIDENew drugDec 16, 2025SYRUP, ORAL |
| OMEPRAZOLE AND SODIUM BICARBONATENew drugDec 10, 2025FOR SUSPENSION, ORAL |
| LOFEXIDINE HYDROCHLORIDENew drugOct 22, 2025TABLET, ORAL |
| CLOMIPHENE CITRATENew drugOct 17, 2025TABLET, ORAL |
| KETOCONAZOLENew drugJul 3, 2025TABLET, ORAL |
| HYDROCORTISONENew drugMay 2, 2025TABLET, ORAL |
| MESALAMINENew drugApr 16, 2025ENEMA, RECTAL |
| FINASTERIDE AND TADALAFILNew drugMar 19, 2025CAPSULE, ORAL |
| INZIRQONew drugJan 28, 2025FOR SUSPENSION, ORAL |
| NABUMETONENew drugJan 7, 2025TABLET, ORAL |
| PRUCALOPRIDE SUCCINATENew drugDec 26, 2024TABLET, ORAL |
| ESTRADIOLNew drugOct 23, 2024GEL, METERED, TRANSDERMAL |
| KETOCONAZOLENew drugSep 16, 2024SHAMPOO, TOPICAL |
| TEZRULYNew drugJul 29, 2024SOLUTION, ORAL |
| L-GLUTAMINENew drugJul 8, 2024FOR SOLUTION, ORAL |
| NAPROXENNew drugJun 12, 2024TABLET, DELAYED RELEASE, ORAL |
| INDOMETHACINNew drugJan 12, 2024SUSPENSION, ORAL |
| ESTRADIOLNew drugSep 6, 2023TABLET, ORAL |
| SILDENAFIL CITRATENew drugAug 29, 2023TABLET, ORAL |
| ESTRADIOLNew drugAug 24, 2023GEL, TRANSDERMAL |
| POTASSIUM CHLORIDENew drugJul 12, 2023FOR SOLUTION, ORAL |
| ALENDRONATE SODIUMNew drugMay 11, 2023SOLUTION, ORAL |
| DEXAMETHASONENew drugMay 9, 2023TABLET, ORAL |
| METHSUXIMIDENew drugMay 1, 2023CAPSULE, ORAL |
| NITROFURANTOINNew drugApr 14, 2023SUSPENSION, ORAL |
| TADALAFILNew drugMar 3, 2023TABLET, ORAL |
| LEVOCARNITINENew drugDec 9, 2022TABLET, ORAL |
| FLUOXETINE HYDROCHLORIDENew drugNov 9, 2022SOLUTION, ORAL |
| TRIMETHOPRIMNew drugOct 28, 2022TABLET, ORAL |
| CARBAMAZEPINENew drugOct 6, 2022SUSPENSION, ORAL |
| LACOSAMIDENew drugAug 26, 2022SOLUTION, ORAL |
| DEXAMETHASONENew drugAug 8, 2022TABLET, ORAL |
| PHENOXYBENZAMINE HYDROCHLORIDENew drugJul 19, 2022CAPSULE, ORAL |
| CLORAZEPATE DIPOTASSIUMNew drugJun 16, 2022TABLET, ORAL |
| PROCHLORPERAZINE MALEATENew drugJun 13, 2022TABLET, ORAL |
| FLUDROCORTISONE ACETATENew drugMay 31, 2022TABLET, ORAL |
| LIDOCAINE HYDROCHLORIDENew drugMar 23, 2022SOLUTION, TOPICAL |
| METHYLTESTOSTERONENew drugFeb 18, 2022CAPSULE, ORAL |
| SULFAMETHOXAZOLE AND TRIMETHOPRIMNew drugFeb 8, 2022SUSPENSION, ORAL |
| SOVUNANew drugJan 14, 2022TABLET, ORAL |
| RIFABUTINNew drugDec 17, 2021CAPSULE, ORAL |
| BETAINENew drugNov 23, 2021FOR SOLUTION, ORAL |
| DIGOXINNew drugNov 22, 2021TABLET, ORAL |
| BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDENew drugNov 4, 2021TABLET, ORAL |
| VALSARTANNew drugNov 2, 2021SOLUTION, ORAL |
| BISOPROLOL FUMARATENew drugOct 29, 2021TABLET, ORAL |
| ATENOLOL AND CHLORTHALIDONENew drugOct 25, 2021TABLET, ORAL |
| CARGLUMIC ACIDNew drugOct 13, 2021TABLET, FOR SUSPENSION, ORAL |
| PAROXETINE HYDROCHLORIDENew drugSep 3, 2021SUSPENSION, ORAL |
| PREDNISONENew drugJul 6, 2021TABLET, ORAL |
| DICYCLOMINE HYDROCHLORIDENew drugApr 23, 2021SYRUP, ORAL |
| FAMOTIDINENew drugApr 20, 2021FOR SUSPENSION, ORAL |
| NAPROXENNew drugMar 10, 2021SUSPENSION, ORAL |
| MELOXICAMNew drugMar 9, 2021CAPSULE, ORAL |
| FLUPHENAZINE HYDROCHLORIDENew drugMar 1, 2021TABLET, ORAL |