FDA.reportPublic FDA data

Application 215523

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL5MGNoNo
002DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL10MGNoNo
003DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL15MGNoNo
004DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL20MGNoNo
005DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL25MGNoNo
006DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL30MGNoNo
007DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL35MGNoNo
008DEXMETHYLPHENIDATE HYDROCHLORIDEDEXMETHYLPHENIDATE HYDROCHLORIDECAPSULE, EXTENDED RELEASE;ORAL40MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-229DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-230DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-231DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-232DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-233DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-234DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-235DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
31722-236DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideCamber Pharmaceuticals, Inc.ANDACurrent
43602-327DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-328DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-329DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-330DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-331DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-332DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-333DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent
43602-334DEXMETHYLPHENIDATE HYDROCHLORIDEdexmethylphenidate hydrochlorideAscent Pharmaceuticals, Inc.ANDACurrent