FDA.reportPublic FDA data

Application 210129

Type
ANDA
Sponsor
INVATECH

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
10135-693Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-693Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
10135-693Amantadine HydrochlorideAmantadine HydrochlorideMarlex Pharmaceuticals IncANDACurrent
16571-834Amantadine HydrochlorideAmantadine HydrochlorideRising Pharma Holdings, Inc.ANDACurrent
24689-105AMANTADINE HYDROCHLORIDEamantadine hydrochlorideAPNAR PHARMA LPANDACurrent
73152-076Amantadine HydrochlorideAmantadine HydrochlorideATHEM LLCANDACurrent