Application 065416

Type
ANDA
Sponsor
ACCORD HLTHCARE

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
16729-019mycophenolate mofetilmycophenolate mofetilAccord Healthcare Inc.ANDACurrent
16729-019mycophenolate mofetilmycophenolate mofetilAccord Healthcare Inc.ANDACurrent
16729-019mycophenolate mofetilmycophenolate mofetilAccord Healthcare Inc.ANDACurrent
16729-019mycophenolate mofetilmycophenolate mofetilAccord Healthcare Inc.ANDACurrent
50090-2541mycophenolate mofetilmycophenolate mofetilA-S Medication SolutionsANDACurrent
50090-2541mycophenolate mofetilmycophenolate mofetilA-S Medication SolutionsANDACurrent
63629-9582mycophenolate mofetilmycophenolate mofetilBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24042ORIG2015-07-06
44239ORIG2009-07-15