FDA.reportPublic FDA data

Application 076822

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001RABEPRAZOLE SODIUMRABEPRAZOLE SODIUMTABLET, DELAYED RELEASE;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0064Rabeprazole SodiumRabeprazole SodiumTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-721Rabeprazole SodiumRabeprazole SodiumAvKARE, Inc.ANDACurrent
42291-721Rabeprazole SodiumRabeprazole SodiumAvKAREANDACurrent
68788-8911Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals Inc.ANDACurrent
68788-8911Rabeprazole SodiumRabeprazole SodiumPreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39517ORIG2013-11-19
31168ORIG2013-11-13