FDA.reportPublic FDA data

Application 074170

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMANTADINE HYDROCHLORIDEAMANTADINE HYDROCHLORIDESYRUP;ORAL50MG/5MLNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50383-807Amantadine HydrochlorideAmantadine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-807Amantadine HydrochlorideAmantadine HydrochlorideAkornANDACurrent
50383-807Amantadine HydrochlorideAmantadine HydrochlorideAkornANDACurrent
50383-807Amantadine HydrochlorideAmantadine HydrochlorideHi-Tech Pharmacal Co., Inc.ANDACurrent
50383-807Amantadine HydrochlorideAmantadine HydrochlorideAkornANDACurrent
68788-7088Amantadine HydrochlorideAmantadine HydrochloridePreferred Pharmaceuticals Inc.ANDACurrent