Application 008975

Type
NDA
Sponsor
ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PURIFIED CORTROPHIN GELCORTICOTROPININJECTABLE;INJECTION40 UNITS/MLNoNo
002PURIFIED CORTROPHIN GELCORTICOTROPININJECTABLE;INJECTION80 UNITS/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
62559-860Purified Cortrophin GelRepository CorticotropinANI Pharmaceuticals, Inc.NDACurrent
62559-860Purified Cortrophin GelRepository CorticotropinANI Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81414SUPPL 2025-03-04
81413SUPPL 2025-03-04
80588SUPPL 2024-12-16
80578SUPPL 2024-12-16
77423SUPPL 2024-02-08
75980SUPPL 2023-10-27
75966SUPPL 2023-10-27
70716SUPPL2022-04-07