Application 091455

Type
ANDA
Sponsor
BARR LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ACITRETINACITRETINCAPSULE;ORAL10MGNoNo
002ACITRETINACITRETINCAPSULE;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1135AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-1136AcitretinAcitretinTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31530ORIG2013-04-09