Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016016
Company: MERCK

Products on NDA 016016

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ALDOCLOR-150	CHLOROTHIAZIDE; METHYLDOPA	150MG;250MG	TABLET;ORAL	Discontinued	None	No	No
ALDOCLOR-250	CHLOROTHIAZIDE; METHYLDOPA	250MG;250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016016

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/20/1968	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
08/22/1999	SUPPL-70	Labeling		Label is not available on this site.
08/05/1997	SUPPL-69	Labeling		Label is not available on this site.
05/23/1997	SUPPL-68	Manufacturing (CMC)-Control		Label is not available on this site.
09/26/1994	SUPPL-67	Manufacturing (CMC)		Label is not available on this site.
12/16/1994	SUPPL-66	Labeling		Label is not available on this site.
06/30/1994	SUPPL-65	Labeling		Label is not available on this site.
09/17/1992	SUPPL-64	Labeling		Label is not available on this site.
09/13/1990	SUPPL-63	Labeling		Label is not available on this site.
09/06/1988	SUPPL-62	Manufacturing (CMC)		Label is not available on this site.
09/03/1992	SUPPL-61	Labeling		Label is not available on this site.
04/21/1988	SUPPL-60	Labeling		Label is not available on this site.
08/26/1987	SUPPL-59	Labeling		Label is not available on this site.
08/15/1988	SUPPL-58	Manufacturing (CMC)-Control		Label is not available on this site.
06/02/1986	SUPPL-57	Labeling		Label is not available on this site.
01/14/1986	SUPPL-56	Labeling		Label is not available on this site.
09/24/1984	SUPPL-55	Labeling		Label is not available on this site.
04/03/1984	SUPPL-54	Labeling		Label is not available on this site.
12/23/1983	SUPPL-53	Manufacturing (CMC)-Formulation		Label is not available on this site.
04/21/1982	SUPPL-52	Labeling		Label is not available on this site.
05/08/1987	SUPPL-51	Labeling		Label is not available on this site.
09/23/1981	SUPPL-50	Labeling		Label is not available on this site.
06/17/1981	SUPPL-49	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/27/1981	SUPPL-48	Labeling		Label is not available on this site.
04/09/1981	SUPPL-47	Manufacturing (CMC)-Control		Label is not available on this site.
01/23/1981	SUPPL-46	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/13/1981	SUPPL-45	Labeling		Label is not available on this site.
11/14/1980	SUPPL-44	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/09/1981	SUPPL-43	Manufacturing (CMC)-Formulation		Label is not available on this site.
11/29/1979	SUPPL-42	Labeling		Label is not available on this site.
07/03/1979	SUPPL-41	Labeling		Label is not available on this site.
09/18/1979	SUPPL-40	Labeling		Label is not available on this site.
03/09/1979	SUPPL-39	Manufacturing (CMC)-Control		Label is not available on this site.
11/07/1978	SUPPL-38	Manufacturing (CMC)-Control		Label is not available on this site.
08/29/1978	SUPPL-37	Manufacturing (CMC)-Control		Label is not available on this site.
06/18/1979	SUPPL-36	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/18/1979	SUPPL-35	Manufacturing (CMC)-Control		Label is not available on this site.
09/12/1978	SUPPL-34	Labeling		Label is not available on this site.
02/15/1978	SUPPL-33	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/12/1978	SUPPL-32	Labeling		Label is not available on this site.
11/09/1976	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
02/19/1976	SUPPL-30	Labeling		Label is not available on this site.
06/06/1975	SUPPL-29	Manufacturing (CMC)-Control		Label is not available on this site.