FDA.reportPublic FDA data

Application 091464

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL5MGNoNo
002SOLIFENACIN SUCCINATESOLIFENACIN SUCCINATETABLET;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5263Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5264Solifenacin SuccinateSolifenacin SuccinateTeva Pharmaceuticals USA, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31531ORIG2014-04-03