FDA.reportPublic FDA data

Application 070589

Type
ANDA
Sponsor
UPSHER SMITH LABS

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
0832-1015Amantadine Hydrochlorideamantadine hydrochlorideUpsher-Smith Laboratories, IncANDACurrent
0832-1015Amantadine Hydrochlorideamantadine hydrochlorideUpsher-Smith Laboratories, IncANDACurrent
0832-1015Amantadine Hydrochlorideamantadine hydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
0832-1015Amantadine Hydrochlorideamantadine hydrochlorideUpsher-Smith Laboratories, LLCANDACurrent
55289-012Amantadine Hydrochlorideamantadine hydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent