Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 016012
Company: TEVA WOMENS

• Medication Guide

• Other Important Information from FDA

Products on NDA 016012

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE	5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No
VIVACTIL	PROTRIPTYLINE HYDROCHLORIDE	10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 016012

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/27/1967	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
07/17/2014	SUPPL-53	Labeling-Package Insert	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/016012Orig1s053ltr.pdf
04/11/2000	SUPPL-52	Labeling		Label is not available on this site.
04/11/2000	SUPPL-51	Labeling		Label is not available on this site.
04/11/2000	SUPPL-50	Labeling		Label is not available on this site.
11/04/1998	SUPPL-49	Manufacturing (CMC)-Control		Label is not available on this site.
12/04/1997	SUPPL-48	Manufacturing (CMC)-Control		Label is not available on this site.
12/27/1996	SUPPL-47	Manufacturing (CMC)-Control		Label is not available on this site.
03/27/2000	SUPPL-46	Labeling		Label is not available on this site.
04/15/1996	SUPPL-45	Manufacturing (CMC)		Label is not available on this site.
03/27/2000	SUPPL-44	Labeling		Label is not available on this site.
06/01/1994	SUPPL-43	Manufacturing (CMC)		Label is not available on this site.
08/26/1993	SUPPL-42	Manufacturing (CMC)-Control		Label is not available on this site.
04/08/1988	SUPPL-41	Manufacturing (CMC)-Packaging		Label is not available on this site.
04/13/1987	SUPPL-40	Labeling		Label is not available on this site.
03/18/1988	SUPPL-39	Manufacturing (CMC)-Control		Label is not available on this site.
01/21/1986	SUPPL-37	Labeling		Label is not available on this site.
09/20/1985	SUPPL-36	Labeling		Label is not available on this site.
07/16/1984	SUPPL-35	Labeling		Label is not available on this site.
06/09/1983	SUPPL-34	Manufacturing (CMC)-Control		Label is not available on this site.
02/18/1982	SUPPL-32	Labeling		Label is not available on this site.
03/06/1981	SUPPL-30	Labeling		Label is not available on this site.
03/10/1981	SUPPL-29	Manufacturing (CMC)-Formulation		Label is not available on this site.
03/10/1981	SUPPL-28	Manufacturing (CMC)-Formulation		Label is not available on this site.
05/12/1980	SUPPL-27	Labeling		Label is not available on this site.
01/29/1980	SUPPL-26	Manufacturing (CMC)		Label is not available on this site.
01/25/1978	SUPPL-24	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/29/1977	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
05/05/1983	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.