FDA.reportPublic FDA data

Application 212582

Type
ANDA
Sponsor
CEROVENE INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL5MGNoNo
002AMPHETAMINE SULFATEAMPHETAMINE SULFATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-897Amphetamine sulfateAmphetamine Sulfate TabletsDR. REDDY'S LABORATORIES INCANDACurrent
43598-897Amphetamine sulfateAmphetamine Sulfate TabletsDR. REDDY'S LABORATORIES INCANDACurrent
43598-898Amphetamine sulfateAmphetamine Sulfate TabletsDR. REDDY'S LABORATORIES INCANDACurrent
43598-898Amphetamine sulfateAmphetamine Sulfate TabletsDR. REDDY'S LABORATORIES INCANDACurrent