Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 012071
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON DEXAMETHASONE SODIUM PHOSPHATE EQ 4MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No
DECADRON DEXAMETHASONE SODIUM PHOSPHATE EQ 24MG PHOSPHATE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** INJECTABLE;INJECTION Discontinued None Yes No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
10/06/1959 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
02/18/2000 SUPPL-53 Manufacturing (CMC)-Control

Label is not available on this site.

10/22/1997 SUPPL-49 Manufacturing (CMC)-Control

Label is not available on this site.

09/09/1997 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1999 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

03/01/1996 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

08/26/1993 SUPPL-39 Labeling

Label is not available on this site.

12/11/1989 SUPPL-38 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/08/1985 SUPPL-31 Labeling

Label is not available on this site.

06/25/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

08/15/1979 SUPPL-26 Labeling

Label is not available on this site.

10/18/1978 SUPPL-25 Labeling

Label is not available on this site.

02/05/1981 SUPPL-23 Manufacturing (CMC)-Packaging

Label is not available on this site.

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