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Granules FDA Approvals

29 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
LISDEXAMFETAMINE DIMESYLATENew drugJan 29, 2025CAPSULE, ORAL
LISDEXAMFETAMINE DIMESYLATENew drugDec 16, 2024TABLET, CHEWABLE, ORAL
BUPROPION HYDROCHLORIDENew drugOct 17, 2024TABLET, EXTENDED RELEASE, ORAL
GLYCOPYRROLATENew drugAug 19, 2024SOLUTION, ORAL
TRAZODONE HYDROCHLORIDENew drugAug 8, 2024TABLET, ORAL
COLCHICINENew drugApr 29, 2024CAPSULE, ORAL
PANTOPRAZOLE SODIUMNew drugDec 11, 2023TABLET, DELAYED RELEASE, ORAL
SILDENAFIL CITRATENew drugDec 1, 2023FOR SUSPENSION, ORAL
ESOMEPRAZOLE MAGNESIUMNew drugOct 18, 2023CAPSULE, DELAYED REL PELLETS, ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDENew drugSep 29, 2023TABLET, ORAL
METOPROLOL SUCCINATENew drugAug 7, 2023TABLET, EXTENDED RELEASE, ORAL
ACETAMINOPHEN AND IBUPROFENNew drugJul 13, 2023TABLET, ORAL
LEVETIRACETAMNew drugJun 13, 2023TABLET, ORAL
METOPROLOL SUCCINATENew drugJun 12, 2023TABLET, EXTENDED RELEASE, ORAL
VENLAFAXINE HYDROCHLORIDENew drugMay 18, 2023CAPSULE, EXTENDED RELEASE, ORAL
GABAPENTINNew drugMar 28, 2023TABLET, ORAL
LOSARTAN POTASSIUMNew drugFeb 23, 2023TABLET, ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATENew drugJan 23, 2023CAPSULE, EXTENDED RELEASE, ORAL
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONENew drugAug 29, 2022TABLET, ORAL
GUAIFENESIN AND PSEUDOEPHEDRINE HYDROCHLORIDENew drugAug 22, 2022TABLET, EXTENDED RELEASE, ORAL
BUPROPION HYDROCHLORIDENew drugFeb 2, 2022TABLET, EXTENDED RELEASE, ORAL
POTASSIUM CHLORIDENew drugJan 27, 2022FOR SOLUTION, ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATENew drugDec 28, 2021TABLET, ORAL
PRAZOSIN HYDROCHLORIDENew drugDec 23, 2021CAPSULE, ORAL
DOFETILIDENew drugOct 14, 2021CAPSULE, ORAL
ACETAMINOPHEN, ASPIRIN AND CAFFEINENew drugFeb 23, 2021TABLET, ORAL
POTASSIUM CHLORIDENew drugFeb 16, 2021CAPSULE, EXTENDED RELEASE, ORAL
POTASSIUM CHLORIDENew drugJan 29, 2021SOLUTION, ORAL
METFORMIN HYDROCHLORIDENew drugJan 14, 2021TABLET, EXTENDED RELEASE, ORAL

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