Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012383
Company: MERCK

Products on NDA 012383

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COLBENEMID	COLCHICINE; PROBENECID	0.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012383

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/27/1961	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
08/18/1994	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
04/20/1994	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
11/30/1989	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
05/12/1988	SUPPL-24	Labeling		Label is not available on this site.
05/12/1988	SUPPL-23	Labeling		Label is not available on this site.
05/12/1988	SUPPL-21	Labeling		Label is not available on this site.
03/02/1982	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
07/23/1985	SUPPL-18	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/24/1979	SUPPL-16	Labeling		Label is not available on this site.
05/10/1979	SUPPL-15	Manufacturing (CMC)		Label is not available on this site.
08/21/1981	SUPPL-14	Labeling		Label is not available on this site.
06/01/1978	SUPPL-13	Labeling		Label is not available on this site.
05/30/1979	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.