FDA.reportPublic FDA data

Application 208315

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL180MGNoNo
002MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL360MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
67877-426MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDAscend Laboratories, LLCANDACurrent
67877-426MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDAscend Laboratories, LLCANDACurrent
67877-427MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDAscend Laboratories, LLCANDACurrent
67877-427MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDAscend Laboratories, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76502ORIG 2023-11-07