FDA.reportPublic FDA data

Application 204232

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZOLMITRIPTANZOLMITRIPTANTABLET;ORAL2.5MGNoNo
002ZOLMITRIPTANZOLMITRIPTANTABLET;ORAL5MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-462ZolmitriptanZolmitriptanAlembic Pharmaceuticals LimitedANDACurrent
46708-462ZolmitriptanZolmitriptanAlembic Pharmaceuticals LimitedANDACurrent
46708-463ZolmitriptanZolmitriptanAlembic Pharmaceuticals LimitedANDACurrent
46708-463ZolmitriptanZolmitriptanAlembic Pharmaceuticals LimitedANDACurrent
64980-203ZolmitriptanzolmitriptanRising Pharmaceuticals, Inc.ANDACurrent
64980-203ZolmitriptanzolmitriptanRising Pharmaceuticals, IANDACurrent
64980-204ZolmitriptanzolmitriptanRising Pharmaceuticals, Inc.ANDACurrent
64980-204ZolmitriptanzolmitriptanRising Pharmaceuticals, IANDACurrent