FDA.reportPublic FDA data

Application 203005

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLATE MOFETILMYCOPHENOLATE MOFETILSUSPENSION;ORAL200MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent
67877-230Mycophenolate mofetilMycophenolate mofetilAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24110ORIG2015-07-02