Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050324
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEODECADRON DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM OINTMENT;OPHTHALMIC 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
09/15/1969 ORIG-1 Approval

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/16/1996 SUPPL-32 Manufacturing (CMC)

Label is not available on this site.

06/12/1995 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1984 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

07/20/1982 SUPPL-29 Labeling

Label is not available on this site.

10/13/1981 SUPPL-28 Labeling

Label is not available on this site.

09/29/1981 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1981 SUPPL-25 Manufacturing (CMC)

Label is not available on this site.

01/13/1981 SUPPL-24 Labeling

Label is not available on this site.

08/28/1980 SUPPL-23 Labeling

Label is not available on this site.

04/01/1980 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

02/17/1978 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

01/27/1978 SUPPL-20 Efficacy-New Indication

Label is not available on this site.

03/23/1977 SUPPL-19 Labeling

Label is not available on this site.

02/23/1976 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1976 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

03/07/1975 SUPPL-16 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/18/1973 SUPPL-15 Labeling

Label is not available on this site.

09/07/1972 SUPPL-14 Labeling

Label is not available on this site.

08/31/1972 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

11/20/1995 SUPPL-12 Labeling

Label is not available on this site.

11/20/1995 SUPPL-11 Labeling

Label is not available on this site.

03/11/1992 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

11/20/1995 SUPPL-9 Labeling

Label is not available on this site.

11/20/1995 SUPPL-8 Labeling

Label is not available on this site.

12/15/1987 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.

04/30/1970 SUPPL-6 Labeling

Label is not available on this site.

12/24/1969 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

09/06/1984 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.

07/10/1984 SUPPL-3 Labeling

Label is not available on this site.

11/03/1969 SUPPL-2 Labeling

Label is not available on this site.

02/28/1984 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

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