FDA.reportPublic FDA data

Application 209047

Type
ANDA
Sponsor
STRIDES PHARMA

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
42543-493Amantadine HydrochlorideAmantadine HydrochlorideStrides Pharma Inc.ANDACurrent
42543-493Amantadine HydrochlorideAmantadine HydrochlorideVensun Pharmaceuticals, IncANDACurrent
53002-3750Amantadine HydrochlorideAmantadine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-3750Amantadine HydrochlorideAmantadine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
71205-223Amantadine HydrochlorideAmantadine HydrochlorideProficient Rx LPANDACurrent
71205-223Amantadine HydrochlorideAmantadine HydrochlorideProficient Rx LPANDACurrent
71335-9618Amantadine HydrochlorideAmantadine HydrochlorideBryant Ranch PrepackANDACurrent