FDA.reportPublic FDA data

Application 076885

Type
ANDA
Sponsor
MYLAN

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
0378-6709Rabeprazole SodiumrabeprazoleMylan Pharmaceuticals Inc.ANDACurrent
0378-6709Rabeprazole SodiumrabeprazoleMylan Pharmaceuticals Inc.ANDACurrent
60429-232Rabeprazole SodiumrabeprazoleGolden State Medical Supply, Inc.ANDACurrent
60429-232Rabeprazole SodiumrabeprazoleGolden State Medical Supply, Inc.ANDACurrent
63187-158Rabeprazole SodiumrabeprazoleProficient Rx LPANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39518ORIG2013-11-19
31173ORIG2013-11-13
31172ORIG2006-01-20