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Macleods Pharms FDA Approvals

89 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
CRISABOROLENew drugSep 24, 2026OINTMENT, TOPICAL
MILNACIPRAN HYDROCHLORIDENew drugSep 15, 2026TABLET, ORAL
NINTEDANIB ESYLATENew drugAug 3, 2026CAPSULE, ORAL
DAPSONENew drugJul 8, 2026TABLET, ORAL
CHLORTHALIDONENew drugJul 1, 2026TABLET, ORAL
RIFAPENTINENew drugJun 23, 2026TABLET, ORAL
BUPROPION HYDROCHLORIDENew drugJun 23, 2026TABLET, EXTENDED RELEASE, ORAL
TOFACITINIB CITRATENew drugJun 3, 2026TABLET, ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATENew drugApr 7, 2026TABLET, ORAL
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENew drugApr 6, 2026TABLET, EXTENDED RELEASE, ORAL
DAPAGLIFLOZINNew drugApr 6, 2026TABLET, ORAL
MEXILETINE HYDROCHLORIDENew drugMar 23, 2026CAPSULE, ORAL
MOXIFLOXACIN HYDROCHLORIDENew drugMar 2, 2026TABLET, ORAL
DILTIAZEM HYDROCHLORIDENew drugFeb 27, 2026CAPSULE, EXTENDED RELEASE, ORAL
COLCHICINENew drugFeb 13, 2026TABLET, ORAL
FENOFIBRATENew drugJan 21, 2026TABLET, ORAL
DOXYCYCLINE HYCLATENew drugDec 9, 2025CAPSULE, ORAL
DOXYCYCLINE HYCLATENew drugNov 19, 2025TABLET, ORAL
TICAGRELORNew drugOct 28, 2025TABLET, ORAL
COLESTIPOL HYDROCHLORIDENew drugSep 15, 2025TABLET, ORAL
POTASSIUM CHLORIDENew drugSep 10, 2025SOLUTION, ORAL
MEMANTINE HYDROCHLORIDENew drugAug 28, 2025CAPSULE, EXTENDED RELEASE, ORAL
OLMESARTAN MEDOXOMIL, AMLODIPINE AND HYDROCHLOROTHIAZIDENew drugJul 18, 2025TABLET, ORAL
MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDENew drugJul 15, 2025CAPSULE, EXTENDED RELEASE, ORAL
OXCARBAZEPINENew drugJul 11, 2025SUSPENSION, ORAL
RIVAROXABANNew drugMay 14, 2025TABLET, ORAL
ZONISAMIDENew drugMay 12, 2025CAPSULE, ORAL
COLESEVELAM HYDROCHLORIDENew drugApr 18, 2025TABLET, ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONENew drugApr 15, 2025TABLET, ORAL
DOXYCYCLINENew drugMar 27, 2025CAPSULE, ORAL
APIXABANNew drugFeb 27, 2025TABLET, ORAL
TRAMADOL HYDROCHLORIDENew drugJan 31, 2025TABLET, EXTENDED RELEASE, ORAL
NEBIVOLOL HYDROCHLORIDENew drugJan 28, 2025TABLET, ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDENew drugJan 28, 2025CAPSULE, ORAL
DESVENLAFAXINE SUCCINATENew drugJan 15, 2025TABLET, EXTENDED RELEASE, ORAL
TELMISARTANNew drugJan 15, 2025TABLET, ORAL
AMLODIPINE BESYLATE, VALSARTAN AND HYDROCHLOROTHIAZIDENew drugJan 7, 2025TABLET, ORAL
ABACAVIR SULFATE AND LAMIVUDINENew drugDec 19, 2024TABLET, ORAL
PIRFENIDONENew drugDec 18, 2024CAPSULE, ORAL
VARENICLINE TARTRATENew drugDec 9, 2024TABLET, ORAL
CLOBETASOL PROPIONATENew drugDec 2, 2024SPRAY, TOPICAL
APREMILASTNew drugNov 25, 2024TABLET, ORAL
CHOLESTYRAMINENew drugNov 21, 2024POWDER, ORAL
FENOFIBRATENew drugNov 13, 2024TABLET, ORAL
PREGABALINNew drugNov 12, 2024CAPSULE, ORAL
ROSUVASTATIN CALCIUMNew drugNov 6, 2024TABLET, ORAL
LANSOPRAZOLENew drugNov 4, 2024CAPSULE, DELAYED REL PELLETS, ORAL
CHOLESTYRAMINE LIGHTNew drugOct 31, 2024POWDER, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugOct 23, 2024CAPSULE, DELAYED REL PELLETS, ORAL
SACUBITRIL AND VALSARTANNew drugOct 16, 2024TABLET, ORAL
AMLODIPINE BESYLATE AND VALSARTANNew drugOct 11, 2024TABLET, ORAL
LINEZOLIDNew drugOct 10, 2024TABLET, ORAL
CEVIMELINE HYDROCHLORIDENew drugSep 20, 2024CAPSULE, ORAL
POTASSIUM CHLORIDENew drugSep 6, 2024TABLET, EXTENDED RELEASE, ORAL
HYDRALAZINE HYDROCHLORIDENew drugAug 21, 2024TABLET, ORAL
LOPINAVIR AND RITONAVIRNew drugJul 25, 2024TABLET, ORAL
CYCLOBENZAPRINE HYDROCHLORIDENew drugJul 22, 2024CAPSULE, EXTENDED RELEASE, ORAL
RASAGILINE MESYLATENew drugJun 28, 2024TABLET, ORAL
DIMETHYL FUMARATENew drugJun 26, 2024CAPSULE, DELAYED RELEASE, ORAL
TROSPIUM CHLORIDENew drugJun 18, 2024TABLET, ORAL
ATORVASTATIN CALCIUMNew drugJun 3, 2024TABLET, ORAL
LACOSAMIDENew drugMay 24, 2024TABLET, ORAL
EFAVIRENZNew drugMay 10, 2024TABLET, ORAL
POTASSIUM CHLORIDENew drugMay 9, 2024TABLET, EXTENDED RELEASE, ORAL
PERPHENAZINENew drugMay 6, 2024TABLET, ORAL
EZETIMIBENew drugApr 29, 2024TABLET, ORAL
SEVELAMER CARBONATENew drugApr 25, 2024FOR SUSPENSION, ORAL
METFORMIN HYDROCHLORIDENew drugMar 13, 2024TABLET, EXTENDED RELEASE, ORAL
SOLIFENACIN SUCCINATENew drugFeb 20, 2024TABLET, ORAL
FENOFIBRIC ACIDNew drugFeb 8, 2024CAPSULE, DELAYED RELEASE, ORAL
CLOBETASOL PROPIONATENew drugDec 28, 2023OINTMENT, TOPICAL
FEBUXOSTATNew drugSep 28, 2023TABLET, ORAL
TRIAMCINOLONE ACETONIDENew drugAug 18, 2023OINTMENT, TOPICAL
LURASIDONE HYDROCHLORIDENew drugJun 9, 2023TABLET, ORAL
OLMESARTAN MEDOXOMIL AND HYDROCHLOROTHIAZIDENew drugJun 1, 2023TABLET, ORAL
SEVELAMER HYDROCHLORIDENew drugMay 26, 2023TABLET, ORAL
METHIMAZOLENew drugMay 24, 2023TABLET, ORAL
PROPYLTHIOURACILNew drugMay 10, 2023TABLET, ORAL
SEVELAMER CARBONATENew drugApr 19, 2023TABLET, ORAL
SILDENAFIL CITRATENew drugApr 19, 2023TABLET, ORAL
REPAGLINIDENew drugMar 22, 2023TABLET, ORAL
LEVOTHYROXINE SODIUMNew drugDec 21, 2022TABLET, ORAL
NYSTATIN AND TRIAMCINOLONE ACETONIDENew drugJul 13, 2022CREAM, TOPICAL
NIACINNew drugMar 3, 2022TABLET, EXTENDED RELEASE, ORAL
EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATENew drugSep 13, 2021TABLET, ORAL
NYSTATIN AND TRIAMCINOLONE ACETONIDENew drugAug 17, 2021OINTMENT, TOPICAL
NYSTATINNew drugAug 10, 2021CREAM, TOPICAL
ACYCLOVIRNew drugMay 19, 2021OINTMENT, TOPICAL
NYSTATINNew drugJan 14, 2021OINTMENT, TOPICAL

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