FDA.reportPublic FDA data

Application 207099

Type
ANDA
Sponsor
EPIC PHARMA LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GABAPENTINGABAPENTINCAPSULE;ORAL100MGNoNo
002GABAPENTINGABAPENTINCAPSULE;ORAL300MGNoNo
003GABAPENTINGABAPENTINCAPSULE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16571-867GabapentinGabapentinRising Pharma Holdings, Inc.ANDACurrent
16571-868GabapentinGabapentinRising Pharma Holdings, Inc.ANDACurrent
16571-869GabapentinGabapentinRising Pharma Holdings, Inc.ANDACurrent
42806-509GabapentinGabapentinEpic Pharma, LLCANDACurrent
42806-510GabapentinGabapentinEpic Pharma, LLCANDACurrent
42806-511GabapentinGabapentinEpic Pharma, LLCANDACurrent
58657-720GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
58657-720GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
58657-721GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
58657-721GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
58657-722GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
58657-722GabapentinGabapentinMethod Pharmaceuticals, LLCANDACurrent
69844-055GabapentinGabapentinGraviti Pharmaceuticals Private LimitedANDACurrent
69844-056GabapentinGabapentinGraviti Pharmaceuticals Private LimitedANDACurrent
69844-057GabapentinGabapentinGraviti Pharmaceuticals Private LimitedANDACurrent