Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012376
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON DEXAMETHASONE 0.5MG/5ML ELIXIR;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
07/07/1960 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
08/27/1993 SUPPL-28 Labeling

Label is not available on this site.

01/12/1989 SUPPL-25 Manufacturing (CMC)-Control

Label is not available on this site.

05/16/1989 SUPPL-22 Labeling

Label is not available on this site.

02/10/1982 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

05/21/1982 SUPPL-18 Labeling

Label is not available on this site.

08/15/1979 SUPPL-17 Labeling

Label is not available on this site.

03/01/1979 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

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