Viewing data from:

VIVACTIL

NDA

PROTRIPTYLINE HYDROCHLORIDE | N016012 | TEVA WOMENS HEALTH INC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain3 active DMFs2 inactive

3 active API suppliers hold Drug Master Files for this ingredient.

OLON SPAPROTRIPTYLINE HYDROCHLORIDE

DMF 83811989

DIPHARMA FRANCIS SRLPROTRIPTYLINE HYDROCHLORIDE

DMF 203652007

EMCURE PHARMACEUTICALS LTDPROTRIPTYLINE HYDROCHLORIDE USP

DMF 236732010

WYCKOFF CHEMICAL CO INCInactivePROTRIPTYLINE HYDROCHLORIDE

DMF 78961989

APICORE LLCInactiveProtriptyline Hydrochloride

DMF 212342008

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 21, 2014	SUPPL -53	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

0 patents0 exclusivities▾

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982