Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012845
Company: PFIZER

Products on NDA 012845

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RENESE	POLYTHIAZIDE	1MG	TABLET;ORAL	Discontinued	None	No	No
RENESE	POLYTHIAZIDE	2MG	TABLET;ORAL	Discontinued	None	No	No
RENESE	POLYTHIAZIDE	4MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012845

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/26/1961	ORIG-1	Approval	Type 1 - New Molecular Entity	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
06/24/1998	SUPPL-26	Labeling		Label is not available on this site.
06/26/1992	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
03/20/1984	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/07/1984	SUPPL-23	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/05/1981	SUPPL-21	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/06/1979	SUPPL-20	Manufacturing (CMC)-Control		Label is not available on this site.
05/22/1978	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
10/06/1977	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1976	SUPPL-17	Labeling		Label is not available on this site.
09/28/1976	SUPPL-16	Manufacturing (CMC)-Formulation		Label is not available on this site.
10/28/1975	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
06/05/1975	SUPPL-13	Manufacturing (CMC)-Control		Label is not available on this site.
05/07/1975	SUPPL-12	Labeling		Label is not available on this site.