FDA.reportPublic FDA data

Application 210279

Type
ANDA
Sponsor
ADARE 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
0527-8106Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8106Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8107Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8107Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8108Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8108Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8109Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8109Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8110Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8110Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8111Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8111Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8112Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8112Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8113Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
0527-8113Dexmethylphenidate Hydrochloridedexmethylphenidate hydrochlorideLannett Company, Inc.ANDACurrent
59917-106Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-107Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-108Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-109Dexmethylphenidate HClDexmethylphenidate HCl Extended-Release Capsules, 20 mgAdare Pharmaceuticals IncANDACurrent
59917-110Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-111Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-112Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent
59917-113Dexmethylphenidate HClDexmethylphenidate HCl Extended-ReleaseAdare Pharmaceuticals IncANDACurrent