Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 009637
Company: AKORN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
HYDROCORTISONE ACETATE HYDROCORTISONE ACETATE 50MG/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
06/25/1997 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
10/26/1981 SUPPL-6 Labeling

Label is not available on this site.

10/26/1981 SUPPL-5 Labeling

Label is not available on this site.

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