FDA.reportPublic FDA data

Application 207571

Type
ANDA
Sponsor
INVAGEN PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68996-101AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDENewGen Pharmaceuticals LLCANDACurrent
69097-925amantadine hydrochlorideamantadine hydrochlorideCipla USA Inc.ANDACurrent
69097-925amantadine hydrochlorideamantadine hydrochlorideCipla USA Inc.ANDACurrent
69844-027amantadine hydrochlorideamantadine hydrochlorideGraviti Pharmaceuticals Private LimitedANDACurrent