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AVENTYL

NDA

NORTRIPTYLINE HYDROCHLORIDE | N014685 | RANBAXY PHARMACEUTICALS INC

1 strength0 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.

SIGMA ALDRICH IRELAND LTDNORTRIPTYLINE HYDROCHLORIDE

DMF 74141988

VASUDHA PHARMA CHEM LTDNORTRIPTYLINE HYDROCHLORIDE USP

DMF 319742017

RL FINE CHEM PVT LTDNORTRIPTYLINE HYDROCHLORIDE

DMF 332272018

DSM PHARMA CHEMICALS SOUTH HAVEN INCInactiveNORTRIPTYLINE HYDROCHLORIDE

DMF 83881990

ZYDUS LIFESCIENCES LTDInactiveNORTRIPTYLINE HYDROCHLORIDE USP

DMF 213302008

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Jul 31, 2007	SUPPL -28	View Letter (PDF)
Jan 13, 2005	SUPPL -26	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.