Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 008975
Company: ANI PHARMS INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PURIFIED CORTROPHIN GEL CORTICOTROPIN 40 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
PURIFIED CORTROPHIN GEL CORTICOTROPIN 80 UNITS/ML INJECTABLE;INJECTION Discontinued None No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/16/1954 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/08/1977 SUPPL-6 Labeling

Label is not available on this site.

05/25/1977 SUPPL-5 Labeling

Label is not available on this site.

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