FDA.reportPublic FDA data

Application 065451

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0480-3571Mycophenolate MofetilMycophenolate MofetilTeva Pharmaceuticals USA, Inc.ANDACurrent
0781-5175Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-5175Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-5175Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-5175Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-5175Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
68084-801Mycophenolate mofetilMycophenolate mofetilAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24043ORIG2015-07-06
23748ORIG2009-07-15