Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 008506
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYDROCORTONE HYDROCORTISONE 10MG TABLET;ORAL Discontinued None No No
HYDROCORTONE HYDROCORTISONE 20MG TABLET;ORAL 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
08/05/1952 ORIG-1 Approval Type 2 New Active Ingredient and Type 4 New Combination PRIORITY

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-25 Manufacturing (CMC)

Label is not available on this site.

05/23/1994 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-22 Labeling

Label is not available on this site.

05/16/1989 SUPPL-16 Labeling

Label is not available on this site.

03/02/1982 SUPPL-15 Manufacturing (CMC)

Label is not available on this site.

08/06/1979 SUPPL-11 Labeling

Label is not available on this site.

08/15/1979 SUPPL-10 Labeling

Label is not available on this site.

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