Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012524
Company: ABBVIE

Products on NDA 012524

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENDURON	METHYCLOTHIAZIDE	2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No
ENDURON	METHYCLOTHIAZIDE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	Yes	No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 012524

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/21/1960	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
04/16/1998	SUPPL-34	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/29/1986	SUPPL-32	Manufacturing (CMC)-Control		Label is not available on this site.
01/25/1984	SUPPL-31	Manufacturing (CMC)-Control		Label is not available on this site.
06/23/1982	SUPPL-30	Labeling		Label is not available on this site.
07/26/1988	SUPPL-29	Labeling		Label is not available on this site.
06/15/1981	SUPPL-27	Labeling		Label is not available on this site.
06/15/1981	SUPPL-26	Labeling		Label is not available on this site.