Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 050322
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
NEODECADRON DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML SOLUTION/DROPS;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
07/02/1969 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
12/29/1998 SUPPL-48 Manufacturing (CMC)-Control

Label is not available on this site.

08/31/1998 SUPPL-47 Manufacturing (CMC)-Control

Label is not available on this site.

02/24/1998 SUPPL-46 Manufacturing (CMC)-Control

Label is not available on this site.

12/23/1997 SUPPL-45 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-44 Manufacturing (CMC)

Label is not available on this site.

04/25/1995 SUPPL-43 Manufacturing (CMC)

Label is not available on this site.

05/05/1995 SUPPL-42 Manufacturing (CMC)-Control

Label is not available on this site.

01/13/1981 SUPPL-41 Labeling

Label is not available on this site.

08/28/1980 SUPPL-40 Labeling

Label is not available on this site.

08/06/1980 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

03/27/1980 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

02/27/1980 SUPPL-37 Manufacturing (CMC)-Control

Label is not available on this site.

03/28/1978 SUPPL-36 Manufacturing (CMC)-Control

Label is not available on this site.

01/24/1978 SUPPL-35 Manufacturing (CMC)-Formulation

Label is not available on this site.

05/16/1977 SUPPL-34 Labeling

Label is not available on this site.

04/18/1977 SUPPL-33 Labeling

Label is not available on this site.

04/12/1977 SUPPL-32 Labeling

Label is not available on this site.

03/15/1976 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

01/09/1976 SUPPL-30 Labeling

Label is not available on this site.

10/17/1975 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

07/08/1975 SUPPL-28 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/17/1973 SUPPL-27 Labeling

Label is not available on this site.

04/23/1973 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

09/13/1972 SUPPL-25 Labeling

Label is not available on this site.

07/18/1972 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

04/27/1972 SUPPL-23 Manufacturing (CMC)-Control

Label is not available on this site.

06/18/1971 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.

04/21/1971 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.

04/30/1970 SUPPL-20 Labeling

Label is not available on this site.

04/14/1970 SUPPL-19 Manufacturing (CMC)-Packaging

Label is not available on this site.

03/02/1970 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

09/29/1995 SUPPL-17 Labeling

Label is not available on this site.

09/29/1995 SUPPL-16 Labeling

Label is not available on this site.

09/29/1995 SUPPL-15 Labeling

Label is not available on this site.

09/29/1995 SUPPL-14 Labeling

Label is not available on this site.

09/29/1995 SUPPL-13 Labeling

Label is not available on this site.

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

Label is not available on this site.

04/03/1987 SUPPL-11 Labeling

Label is not available on this site.

01/22/1986 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

10/30/1985 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.

03/07/1985 SUPPL-8 Labeling

Label is not available on this site.

06/27/1984 SUPPL-7 Labeling

Label is not available on this site.

02/06/1970 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.

08/27/1984 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

02/02/1984 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

04/22/1983 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

02/25/1983 SUPPL-2 Manufacturing (CMC)-Control

Label is not available on this site.

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