Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 001546
Company: MERCK SHARP DOHME

Products on NDA 001546

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
GUANIDINE HYDROCHLORIDE	GUANIDINE HYDROCHLORIDE	125MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 001546

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/1939	ORIG-1	Approval		UNKNOWN		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/03/2015	SUPPL-22	Manufacturing (CMC)		Label is not available on this site.
09/30/2014	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
06/16/2000	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
02/14/2000	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
12/23/1998	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
10/28/1992	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
04/24/2002	SUPPL-11	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/1546s011.pdf
12/11/1986	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
12/05/1984	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
08/02/1983	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/16/1980	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/16/1978	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
09/23/1976	SUPPL-5	Labeling		Label is not available on this site.
01/29/1975	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.