Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018061
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TIMOLIDE 10-25 HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE 25MG;10MG TABLET;ORAL 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
12/11/1981 ORIG-1 Approval Type 4 - New Combination 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
04/05/2002 SUPPL-30 Manufacturing (CMC)

Label is not available on this site.

03/04/2003 SUPPL-29 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18061slr029ltr.pdf
05/15/1998 SUPPL-28 Labeling

Label is not available on this site.

02/13/1998 SUPPL-27 Manufacturing (CMC)-Control

Label is not available on this site.

05/04/1998 SUPPL-26 Manufacturing (CMC)

Label is not available on this site.

10/13/1998 SUPPL-25 Labeling

Label is not available on this site.

07/09/1997 SUPPL-24 Manufacturing (CMC)-Control

Label is not available on this site.

02/09/1994 SUPPL-23 Labeling

Label is not available on this site.

01/22/1993 SUPPL-22 Labeling

Label is not available on this site.

08/12/1991 SUPPL-21 Labeling

Label is not available on this site.

04/21/1989 SUPPL-20 Manufacturing (CMC)

Label is not available on this site.

02/03/1988 SUPPL-19 Labeling

Label is not available on this site.

06/01/1987 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

04/08/1987 SUPPL-17 Labeling

Label is not available on this site.

08/26/1987 SUPPL-16 Labeling

Label is not available on this site.

08/15/1988 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.

08/08/1986 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.

06/02/1986 SUPPL-13 Labeling

Label is not available on this site.

09/06/1985 SUPPL-12 Labeling

Label is not available on this site.

10/04/1984 SUPPL-11 Labeling

Label is not available on this site.

04/18/1984 SUPPL-10 Labeling

Label is not available on this site.

08/24/1983 SUPPL-9 Labeling

Label is not available on this site.

12/23/1983 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.

09/20/1982 SUPPL-6 Labeling

Label is not available on this site.

09/20/1982 SUPPL-5 Labeling

Label is not available on this site.

02/03/1988 SUPPL-4 Efficacy-New Dosing Regimen

Label is not available on this site.

02/24/1982 SUPPL-3 Manufacturing (CMC)-Formulation

Label is not available on this site.

03/13/2009 SUPPL-2 Efficacy-New Patient Population

Label is not available on this site.

05/07/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

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