Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 011984
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
DECADRON DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE SOLUTION/DROPS;OPHTHALMIC, OTIC 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
09/02/1959 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
07/31/1997 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

08/29/1997 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-44 Manufacturing (CMC)-Control

Label is not available on this site.

12/02/1996 SUPPL-43 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-42 Manufacturing (CMC)

Label is not available on this site.

04/25/1995 SUPPL-41 Manufacturing (CMC)-Packaging

Label is not available on this site.

12/22/1994 SUPPL-40 Manufacturing (CMC)-Control

Label is not available on this site.

10/21/1994 SUPPL-39 Labeling

Label is not available on this site.

04/18/1991 SUPPL-36 Labeling

Label is not available on this site.

02/16/1988 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

10/17/1988 SUPPL-34 Labeling

Label is not available on this site.

02/16/1988 SUPPL-33 Labeling

Label is not available on this site.

02/25/1986 SUPPL-31 Manufacturing (CMC)

Label is not available on this site.

10/17/1988 SUPPL-30 Labeling

Label is not available on this site.

12/06/1984 SUPPL-29 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-28 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/15/1982 SUPPL-26 Labeling

Label is not available on this site.

02/16/1988 SUPPL-25 Labeling

Label is not available on this site.

10/27/1981 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

10/09/1981 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

12/01/1980 SUPPL-22 Labeling

Label is not available on this site.

07/15/1981 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

05/14/1982 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

09/17/1980 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.

05/28/1980 SUPPL-18 Labeling

Label is not available on this site.

08/26/1979 SUPPL-17 Labeling

Label is not available on this site.

01/08/1980 SUPPL-16 Labeling

Label is not available on this site.

05/19/1976 SUPPL-15 Labeling

Label is not available on this site.

04/21/1976 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

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