FDA.reportPublic FDA data

Application 076356

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CLARAVISISOTRETINOINCAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent
0555-1054ClaravisIsotretinoinTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24054ORIG2015-07-02
23820ORIG2005-07-28