Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018201
Company: MERCK
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MODURETIC 5-50 AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE EQ 5MG ANHYDROUS;50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** TABLET;ORAL Discontinued None Yes No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
10/05/1981 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
02/25/2003 SUPPL-40 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18200slr026,18201slr040ltr.pdf
06/24/2002 SUPPL-39 Manufacturing (CMC)

Label is not available on this site.

04/05/2002 SUPPL-38 Manufacturing (CMC)

Label is not available on this site.

03/21/2002 SUPPL-37 Labeling Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/18200s24ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200s024_Midamor.cfm
09/18/2001 SUPPL-36 Labeling

Label is not available on this site.

02/12/1998 SUPPL-35 Manufacturing (CMC)-Control

Label is not available on this site.

08/24/1998 SUPPL-34 Labeling

Label is not available on this site.

11/29/1995 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

12/09/1993 SUPPL-32 Labeling

Label is not available on this site.

10/01/1992 SUPPL-31 Labeling

Label is not available on this site.

09/17/1992 SUPPL-30 Labeling

Label is not available on this site.

03/26/1992 SUPPL-29 Manufacturing (CMC)-Control

Label is not available on this site.

05/14/1991 SUPPL-26 Manufacturing (CMC)-Control

Label is not available on this site.

04/12/1989 SUPPL-25 Labeling

Label is not available on this site.

03/29/1988 SUPPL-24 Manufacturing (CMC)

Label is not available on this site.

04/21/1988 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

07/10/1987 SUPPL-22 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/01/1987 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/09/1987 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

08/26/1987 SUPPL-19 Labeling

Label is not available on this site.

08/15/1988 SUPPL-18 Manufacturing (CMC)-Control

Label is not available on this site.

01/21/1986 SUPPL-17 Labeling

Label is not available on this site.

11/01/1985 SUPPL-16 Labeling

Label is not available on this site.

05/05/1988 SUPPL-15 Labeling

Label is not available on this site.

09/10/1985 SUPPL-14 Manufacturing (CMC)-Control

Label is not available on this site.

06/14/1985 SUPPL-13 Labeling

Label is not available on this site.

07/16/1986 SUPPL-12 Labeling

Label is not available on this site.

02/07/1985 SUPPL-11 Labeling

Label is not available on this site.

08/28/1984 SUPPL-10 Labeling

Label is not available on this site.

04/19/1984 SUPPL-9 Labeling

Label is not available on this site.

01/04/1984 SUPPL-7 Manufacturing (CMC)-Formulation

Label is not available on this site.

12/23/1983 SUPPL-6 Manufacturing (CMC)

Label is not available on this site.

03/01/1983 SUPPL-5 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/08/1982 SUPPL-4 Manufacturing (CMC)-Packaging

Label is not available on this site.

06/04/1982 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

03/03/1982 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

02/08/1982 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/21/2002 SUPPL-37 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/18-200S024_Midamor_Prntlbl.pdf

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