Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012052
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTONE HYDROCORTISONE SODIUM PHOSPHATE EQ 50MG BASE/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
06/08/1960 ORIG-1 Approval Type 3 - New Dosage Form 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
12/01/1997 SUPPL-51 Manufacturing (CMC)-Control

Label is not available on this site.

05/02/1997 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

01/16/1997 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1996 SUPPL-45 Manufacturing (CMC)

Label is not available on this site.

02/29/1996 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1993 SUPPL-42 Labeling

Label is not available on this site.

09/10/1993 SUPPL-41 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1989 SUPPL-40 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1985 SUPPL-34 Labeling

Label is not available on this site.

02/23/1984 SUPPL-33 Labeling

Label is not available on this site.

01/15/1986 SUPPL-32 Manufacturing (CMC)-Control

Label is not available on this site.

10/16/1981 SUPPL-29 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/14/1980 SUPPL-27 Labeling

Label is not available on this site.

06/27/1977 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

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