FDA.reportPublic FDA data

Application 209171

Type
ANDA
Sponsor
HERITAGE 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
0615-8263Amantadine HydrochlorideAmantadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8263Amantadine HydrochlorideAmantadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-7042Amantadine HydrochlorideAmantadine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-7042Amantadine HydrochlorideAmantadine HydrochlorideMajor PharmaceuticalsANDACurrent
23155-362Amantadine HydrochlorideAmantadine HydrochlorideHeritage Pharmaceuticals Inc.ANDACurrent
23155-362Amantadine HydrochlorideAmantadine HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-362Amantadine HydrochlorideAmantadine HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-362Amantadine HydrochlorideAmantadine HydrochlorideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent