FDA.reportPublic FDA data

Application 207570

Type
ANDA
Sponsor
INVAGEN 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
68996-102AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDENewGen Pharmaceuticals LLCANDACurrent
69097-926Amantadine hydrochlorideAmantadine hydrochlorideCipla USA Inc.ANDACurrent
69844-026Amantadine hydrochlorideAmantadine hydrochlorideGraviti Pharmaceuticals Private LimitedANDACurrent