FDA.reportPublic FDA data

Application 214957

Type
ANDA
Sponsor
ASCENT PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINTABLET;ORAL600MGNoNo
002GABAPENTINGABAPENTINTABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
31722-166GABAPENTINGabapentinCamber Pharmaceuticals, Inc.ANDACurrent
31722-167GABAPENTINGabapentinCamber Pharmaceuticals, Inc.ANDACurrent
43602-466GABAPENTINGabapentinAscent Pharmaceuticals, IncANDACurrent
43602-467GABAPENTINGabapentinAscent Pharmaceuticals, IncANDACurrent
50090-6189GABAPENTINGabapentinA-S Medication SolutionsANDACurrent
71610-621GABAPENTINGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-621GABAPENTINGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-630GABAPENTINGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-630GABAPENTINGabapentinAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-394GabapentinGabapentinDirect_RxANDACurrent
72189-394GabapentinGabapentinDirect_RxANDACurrent
76282-706GABAPENTINGabapentinExelan Pharmaceuticals, Inc.ANDACurrent
76282-706GABAPENTINGabapentinExelan Pharmaceuticals, Inc.ANDACurrent
76282-707GABAPENTINGabapentinExelan Pharmaceuticals, Inc.ANDACurrent
76282-707GABAPENTINGabapentinExelan Pharmaceuticals, Inc.ANDACurrent