FDA.reportPublic FDA data

Application 214376

Type
ANDA
Sponsor
AMTA

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
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-172Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
70436-173Mycophenolic AcidMycophenolic AcidSlate Run Pharmaceuticals, LLCANDACurrent
72322-1048Mycophenolic AcidMycophenolic AcidAMTA LABS LIMITEDANDACurrent
72322-1049Mycophenolic AcidMycophenolic AcidAMTA LABS LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76498ORIG 2023-11-07