Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 017503
Company: BOEHRINGER INGELHEIM

Products on NDA 017503

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
COMBIPRES	CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE	15MG;0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COMBIPRES	CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE	15MG;0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
COMBIPRES	CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE	15MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No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 017503

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/03/1974	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/15/1999	SUPPL-28	Manufacturing (CMC)		Label is not available on this site.
04/08/1991	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
02/20/1991	SUPPL-26	Labeling		Label is not available on this site.
08/07/1987	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
03/26/1987	SUPPL-24	Labeling		Label is not available on this site.
04/10/1986	SUPPL-23	Labeling		Label is not available on this site.
10/02/1985	SUPPL-22	Labeling		Label is not available on this site.
12/18/1984	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
02/25/1985	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/1984	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
08/01/1984	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
04/10/1984	SUPPL-17	Labeling		Label is not available on this site.
03/09/1983	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
07/31/1981	SUPPL-15	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/09/1981	SUPPL-14	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/28/1980	SUPPL-13	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/15/1981	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/28/1980	SUPPL-11	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/28/1980	SUPPL-10	Manufacturing (CMC)-Formulation		Label is not available on this site.
02/26/1980	SUPPL-9	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/26/1980	SUPPL-8	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/31/1979	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/05/1981	SUPPL-5	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/10/1976	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/17/1977	SUPPL-3	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/09/1976	SUPPL-2	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/08/1976	SUPPL-1	Manufacturing (CMC)-Packaging		Label is not available on this site.