FDA.reportPublic FDA data

Application 203013

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL75MGNoNo
002BUPROPION HYDROCHLORIDEBUPROPION HYDROCHLORIDETABLET;ORAL100MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-118Bupropion HydrochlorideBupropion HydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-118Bupropion HydrochlorideBupropion HydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-127Bupropion HydrochlorideBupropion HydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
46708-127Bupropion HydrochlorideBupropion HydrochlorideAlembic Pharmaceuticals LimitedANDACurrent
64980-201Bupropion HydrochlorideBupropion HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
64980-202Bupropion HydrochlorideBupropion HydrochlorideRising Pharmaceuticals, Inc.ANDACurrent
68071-5213Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5213Bupropion HydrochlorideBupropion HydrochlorideNuCare Pharmaceuticals,Inc.ANDACurrent
71335-1551Bupropion HydrochlorideBupropion HydrochlorideBryant Ranch PrepackANDACurrent