FDA.reportPublic FDA data

Application 212988

Type
ANDA
Sponsor
ESKAYEF

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREGABALINPREGABALINCAPSULE;ORAL25MGNoNo
002PREGABALINPREGABALINCAPSULE;ORAL50MGNoNo
003PREGABALINPREGABALINCAPSULE;ORAL75MGNoNo
004PREGABALINPREGABALINCAPSULE;ORAL100MGNoNo
005PREGABALINPREGABALINCAPSULE;ORAL150MGNoNo
006PREGABALINPREGABALINCAPSULE;ORAL200MGNoNo
007PREGABALINPREGABALINCAPSULE;ORAL225MGNoNo
008PREGABALINPREGABALINCAPSULE;ORAL300MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
72658-0808PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0809PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0810PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0811PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0812PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0813PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0814PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
72658-0849PREGABALINPREGABALINEskayef Pharmaceuticals LimitedANDACurrent
75834-296PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-297PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-298PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-299PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-300PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-301PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-302PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent
75834-303PREGABALINPREGABALINNivagen Pharmaceuticals, Inc.ANDACurrent