Application 214871

Type
ANDA
Sponsor
AMNEAL

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
69238-1595Mycophenolate MofetilMycophenolate MofetilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1595Mycophenolate MofetilMycophenolate MofetilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1595Mycophenolate MofetilMycophenolate MofetilAmneal Pharmaceuticals NY LLCANDACurrent
69238-1595Mycophenolate MofetilMycophenolate MofetilAmneal Pharmaceuticals NY LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76504ORIG 2023-11-07