Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008228
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTONE HYDROCORTISONE ACETATE 25MG/ML INJECTABLE;INJECTION Discontinued None No No
HYDROCORTONE 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
12/21/1951 ORIG-1 Approval Type 2 - New Active Ingredient 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
03/01/1996 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/10/1995 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

08/27/1993 SUPPL-27 Labeling

Label is not available on this site.

02/12/1992 SUPPL-26 Manufacturing (CMC)-Formulation

Label is not available on this site.

09/30/1985 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

10/03/1984 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

05/16/1989 SUPPL-19 Labeling

Label is not available on this site.

10/16/1981 SUPPL-16 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/15/1979 SUPPL-13 Labeling

Label is not available on this site.

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