Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011860
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HUMORSOL DEMECARIUM BROMIDE 0.25% SOLUTION/DROPS;OPHTHALMIC Discontinued None No No
HUMORSOL DEMECARIUM BROMIDE 0.125% 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
08/05/1959 ORIG-1 Approval Type 1 - New Molecular Entity 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
04/15/1998 SUPPL-31 Manufacturing (CMC)-Control

Label is not available on this site.

05/29/1998 SUPPL-30 Manufacturing (CMC)-Control

Label is not available on this site.

03/04/1997 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

02/20/1997 SUPPL-28 Manufacturing (CMC)-Control

Label is not available on this site.

01/30/1997 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

04/16/1996 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

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

Label is not available on this site.

12/22/1993 SUPPL-24 Labeling

Label is not available on this site.

04/23/1991 SUPPL-23 Labeling

Label is not available on this site.

01/13/1988 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

02/25/1986 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/12/1986 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

12/06/1984 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

06/14/1984 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.

10/27/1981 SUPPL-16 Manufacturing (CMC)

Label is not available on this site.

10/13/1981 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

05/06/1987 SUPPL-14 Labeling

Label is not available on this site.

07/15/1981 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.

12/21/1979 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

07/05/1978 SUPPL-11 Labeling

Label is not available on this site.

04/21/1976 SUPPL-10 Manufacturing (CMC)-Control

Label is not available on this site.

06/22/1978 SUPPL-8 Labeling

Label is not available on this site.

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