FDA.reportPublic FDA data

Application 212044

Type
ANDA
Sponsor
RUBICON

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
72888-033Amantadine HydrochlorideAmantadine HydrochlorideAdvagen Pharma LimitedANDACurrent
72888-033Amantadine HydrochlorideAmantadine HydrochlorideAdvagen Pharma LimitedANDACurrent
72888-033Amantadine HydrochlorideAmantadine HydrochlorideAdvagen Pharma LimitedANDACurrent
72888-033Amantadine HydrochlorideAmantadine HydrochlorideAdvagen Pharma LimitedANDACurrent