FDA.reportPublic FDA data

Application 210215

Type
ANDA
Sponsor
INVATECH

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
10135-692Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-692Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-692Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
24689-112AMANTADINE HYDROCHLORIDEamantadine hydrochlorideApnar Pharma LPANDACurrent
73152-075Amantadine HydrochlorideAmantadine HydrochlorideAthem LLCANDACurrent