Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 016675
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON-LA DEXAMETHASONE ACETATE EQ 8MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
09/06/1973 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-32 Manufacturing (CMC)

Label is not available on this site.

08/27/1993 SUPPL-28 Labeling

Label is not available on this site.

12/11/1989 SUPPL-27 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1985 SUPPL-20 Labeling

Label is not available on this site.

05/16/1989 SUPPL-19 Labeling

Label is not available on this site.

02/21/1983 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/04/1982 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.

12/21/1981 SUPPL-15 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/03/1981 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1979 SUPPL-12 Labeling

Label is not available on this site.

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