FDA.reportPublic FDA data

Application 208278

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDECAPSULE;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6630amantadine hydrochlorideamantadine hydrochlorideMajor PharmaceuticalsANDACurrent
0904-6630amantadine hydrochlorideamantadine hydrochlorideMajor PharmaceuticalsANDACurrent
65841-835amantadine hydrochlorideamantadine hydrochlorideCadila Healthcare LimitedANDACurrent
65841-835amantadine hydrochlorideamantadine hydrochlorideCadila Healthcare LimitedANDACurrent
65841-835amantadine hydrochlorideamantadine hydrochlorideCadila Healthcare LimitedANDACurrent
68382-512amantadine hydrochlorideamantadine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-512amantadine hydrochlorideamantadine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-512amantadine hydrochlorideamantadine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
68788-6975amantadine hydrochlorideamantadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6975amantadine hydrochlorideamantadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6975amantadine hydrochlorideamantadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
68788-6975amantadine hydrochlorideamantadine hydrochloridePreferred Pharmaceuticals Inc.ANDACurrent
71205-702amantadine hydrochlorideamantadine hydrochlorideProficient Rx LPANDACurrent
71335-0469amantadine hydrochlorideamantadine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0469amantadine hydrochlorideamantadine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0469amantadine hydrochlorideamantadine hydrochlorideBryant Ranch PrepackANDACurrent
71335-0469amantadine hydrochlorideamantadine hydrochlorideBryant Ranch PrepackANDACurrent