Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012775
Company: ABBOTT

Products on NDA 012775

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENDURONYL	DESERPIDINE; METHYCLOTHIAZIDE	0.25MG;5MG	TABLET;ORAL	Discontinued	None	No	No
ENDURONYL FORTE	DESERPIDINE; METHYCLOTHIAZIDE	0.5MG;5MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012775

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/01/1961	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
04/16/1998	SUPPL-36	Manufacturing (CMC)-Packaging		Label is not available on this site.
09/25/1991	SUPPL-35	Labeling		Label is not available on this site.
11/17/1987	SUPPL-34	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
09/25/1991	SUPPL-33	Labeling		Label is not available on this site.
08/29/1986	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
07/28/1986	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
01/05/1984	SUPPL-30	Labeling		Label is not available on this site.
08/25/1982	SUPPL-29	Labeling		Label is not available on this site.
10/05/1981	SUPPL-27	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/22/1981	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/1981	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
12/12/1980	SUPPL-24	Manufacturing (CMC)-Formulation		Label is not available on this site.
01/03/1980	SUPPL-23	Labeling		Label is not available on this site.