Application 210423

Type
ANDA
Sponsor
ALEMBIC PHARMS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACETAZOLAMIDEACETAZOLAMIDECAPSULE, EXTENDED RELEASE;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
46708-349AcetazolamideAcetazolamideAlembic Pharmaceuticals LimitedANDACurrent
62332-349AcetazolamideAcetazolamideAlembic Pharmaceuticals Inc.ANDACurrent
62332-349AcetazolamideAcetazolamideAlembic Pharmaceuticals Inc.ANDACurrent
62332-349AcetazolamideAcetazolamideAlembic Pharmaceuticals Inc.ANDACurrent