FDA.reportPublic FDA data

Application 065379

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILCAPSULE;ORAL250MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2067Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-2067Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-2067Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-2067Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
0781-2067Mycophenolate MofetilMycophenolate MofetilSandoz IncANDACurrent
68084-795Mycophenolate MofetilMycophenolate MofetilAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44522ORIG2015-07-06
44234ORIG2009-07-15