FDA.reportPublic FDA data

Application 065521

Type
ANDA
Sponsor
MYLAN

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
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals Inc.ANDACurrent
0378-4472Mycophenolate Mofetilmycophenolate mofetilMylan Pharmaceuticals IncANDACurrent
51079-379Mycophenolate Mofetilmycophenolate mofetilMylan Institutional Inc.ANDACurrent
51079-379Mycophenolate Mofetilmycophenolate mofetilMylan Institutional Inc.ANDACurrent
51079-379Mycophenolate Mofetilmycophenolate mofetilMylan Institutional Inc.ANDACurrent
51079-379Mycophenolate Mofetilmycophenolate mofetilMylan Institutional Inc.ANDACurrent
55154-5382Mycophenolate Mofetilmycophenolate mofetilCardinal HealthANDACurrent
55154-5382Mycophenolate Mofetilmycophenolate mofetilCardinal HealthANDACurrent
55154-5382Mycophenolate Mofetilmycophenolate mofetilCardinal Health 107, LLCANDACurrent
55154-5382Mycophenolate Mofetilmycophenolate mofetilCardinal HealthANDACurrent
55154-5382Mycophenolate Mofetilmycophenolate mofetilCardinal HealthANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical Supply, Inc.ANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical Supply, Inc.ANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical SupplyANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical SupplyANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical Supply, Inc.ANDACurrent
60429-070Mycophenolate Mofetilmycophenolate mofetilGolden State Medical Supply, Inc.ANDACurrent
71610-033Mycophenolate Mofetilmycophenolate mofetilAphena Pharma Solutions - Tennessee, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44524ORIG2015-07-06
44246ORIG2009-07-15