Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012359
Company: SHIRE

Products on NDA 012359

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SALUTENSIN	HYDROFLUMETHIAZIDE; RESERPINE	50MG;0.125MG	TABLET;ORAL	Discontinued	None	No	No
SALUTENSIN-DEMI	HYDROFLUMETHIAZIDE; RESERPINE	25MG;0.125MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012359

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/20/1960	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
06/24/1996	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
10/07/1992	SUPPL-31	Manufacturing (CMC)		Label is not available on this site.
07/09/1990	SUPPL-30	Manufacturing (CMC)		Label is not available on this site.
06/22/1988	SUPPL-29	Labeling		Label is not available on this site.
10/24/1986	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
06/27/1986	SUPPL-27	Manufacturing (CMC)		Label is not available on this site.
08/01/1985	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
07/29/1985	SUPPL-25	Labeling		Label is not available on this site.
06/08/1984	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/23/1983	SUPPL-23	Labeling		Label is not available on this site.
05/10/1984	SUPPL-22	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/03/1982	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
03/03/1982	SUPPL-20	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/03/1981	SUPPL-19	Labeling		Label is not available on this site.
07/29/1985	SUPPL-18	Labeling		Label is not available on this site.
06/10/1982	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
07/31/1979	SUPPL-16	Labeling		Label is not available on this site.
10/03/1980	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
10/03/1980	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1978	SUPPL-13	Labeling		Label is not available on this site.
05/15/1978	SUPPL-12	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/27/1978	SUPPL-11	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1978	SUPPL-10	Manufacturing (CMC)-Control		Label is not available on this site.
05/15/1978	SUPPL-9	Manufacturing (CMC)-Formulation		Label is not available on this site.
06/23/1977	SUPPL-6	Labeling		Label is not available on this site.
12/13/1977	SUPPL-5	Unspecified		Label is not available on this site.
06/23/1977	SUPPL-3	Manufacturing (CMC)-Formulation		Label is not available on this site.