FDA.reportPublic FDA data

Application 203578

Type
ANDA
Sponsor
AMNEAL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIACINNIACINTABLET, EXTENDED RELEASE;ORAL500MGNoNo
002NIACINNIACINTABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10135-612NiacinNiacinMarlex Pharmaceuticals IncANDACurrent
10135-613NiacinNiacinMarlex Pharmaceuticals IncANDACurrent
10135-614NiacinNiacinMarlex Pharmaceuticals IncANDACurrent
50268-584NiacinNiacinAvPAKANDACurrent
50268-584NiacinNiacinAvPAKANDACurrent
50268-584NiacinNiacinAvPAKANDACurrent
50268-586NiacinNiacinAvPAKANDACurrent
65162-321NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-321NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-321NiacinNiacinAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-321NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-321NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-323NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-323NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-323NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent
65162-323NiacinNiacinAmneal Pharmaceuticals of New York, LLCANDACurrent
65162-323NiacinNiacinAmneal Pharmaceuticals LLCANDACurrent