FDA.reportPublic FDA data

Application 091558

Type
ANDA
Sponsor
APOTEX INC

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
0904-6785Mycophenolic AcidMycophenolic AcidMajor PharmaceuticalsANDACurrent
0904-6785Mycophenolic AcidMycophenolic AcidMajor PharmaceuticalsANDACurrent
0904-6786Mycophenolic AcidMycophenolic AcidMajor PharmaceuticalsANDACurrent
0904-6786Mycophenolic AcidMycophenolic AcidMajor PharmaceuticalsANDACurrent
50268-559Mycophenolic AcidMycophenolic AcidAvPAKANDACurrent
50268-559Mycophenolic AcidMycophenolic AcidAvPAKANDACurrent
50268-559Mycophenolic AcidMycophenolic AcidAvPAKANDACurrent
50268-560Mycophenolic AcidMycophenolic AcidAvPAKANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical SupplyANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical SupplyANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-016Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical SupplyANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical SupplyANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60429-017Mycophenolic AcidMycophenolic AcidGolden State Medical Supply, Inc.ANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2965Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
60505-2966Mycophenolic AcidMycophenolic AcidApotex CorpANDACurrent
68084-907Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-907Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-907Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-907Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-907Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-918Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-918Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-918Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-918Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
68084-918Mycophenolic AcidMycophenolic AcidAmerican Health PackagingANDACurrent
70518-3218Mycophenolic AcidMycophenolic AcidREMEDYREPACK INC.ANDACurrent
70518-3255Mycophenolic AcidMycophenolic AcidREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
44557ORIG2015-07-02