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Chartwell Rx FDA Approvals

33 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
NICARDIPINE HYDROCHLORIDENew drugJun 25, 2025CAPSULE, ORAL
SUCRALFATENew drugApr 14, 2025SUSPENSION, ORAL
ERLOTINIB HYDROCHLORIDENew drugSep 13, 2024TABLET, ORAL
GLYCOPYRROLATENew drugAug 28, 2024SOLUTION, ORAL
LACOSAMIDENew drugMay 15, 2024SOLUTION, ORAL
OLMESARTAN MEDOXOMILNew drugJan 25, 2024TABLET, ORAL
DAPSONENew drugNov 1, 2023GEL, TOPICAL
DAPSONENew drugOct 31, 2023GEL, TOPICAL
BREXPIPRAZOLENew drugOct 25, 2023TABLET, ORAL
EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENew drugOct 3, 2023TABLET, ORAL
PIRFENIDONENew drugAug 28, 2023CAPSULE, ORAL
PIRFENIDONENew drugAug 23, 2023TABLET, ORAL
SEVELAMER CARBONATENew drugMar 2, 2023FOR SUSPENSION, ORAL
TRIAMCINOLONE ACETONIDENew drugJan 27, 2023OINTMENT, TOPICAL
FESOTERODINE FUMARATENew drugJan 5, 2023TABLET, EXTENDED RELEASE, ORAL
RUFINAMIDENew drugNov 7, 2022SUSPENSION, ORAL
FLUDROCORTISONE ACETATENew drugOct 27, 2022TABLET, ORAL
ARIPIPRAZOLENew drugOct 25, 2022SOLUTION, ORAL
FLUOXETINE HYDROCHLORIDENew drugSep 13, 2022TABLET, ORAL
MECLIZINE HYDROCHLORIDENew drugAug 11, 2022TABLET, ORAL
DROXIDOPANew drugMay 5, 2022CAPSULE, ORAL
NEBIVOLOL HYDROCHLORIDENew drugMar 31, 2022TABLET, ORAL
VIGABATRINNew drugMar 10, 2022FOR SOLUTION, ORAL
MIGLUSTATNew drugFeb 3, 2022CAPSULE, ORAL
HALCINONIDENew drugSep 8, 2021CREAM, TOPICAL
OXCARBAZEPINENew drugJun 21, 2021SUSPENSION, ORAL
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATENew drugJun 4, 2021TABLET, ORAL
DEFERASIROXNew drugMay 27, 2021TABLET, ORAL
SILDENAFIL CITRATENew drugApr 29, 2021FOR SUSPENSION, ORAL
CLOBETASOL PROPIONATENew drugMar 26, 2021CREAM, TOPICAL
TAVABOROLENew drugFeb 3, 2021SOLUTION, TOPICAL
SEVELAMER CARBONATENew drugJan 14, 2021TABLET, ORAL
LIDOCAINENew drugJan 5, 2021OINTMENT, TOPICAL

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