FDA.reportPublic FDA data

Application 091224

Type
ANDA
Sponsor
TEVA PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-7621PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7621PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7621PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7624PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7624PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7625PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7625PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7626PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7626PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7626PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7627PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7627PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7627PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7628PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7628PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-7628PregabalinPregabalinTeva Pharmaceuticals USA, Inc.ANDACurrent