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ELAVIL

NDA

AMITRIPTYLINE HYDROCHLORIDE | N012704 | ASTRAZENECA PHARMACEUTICALS LP

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 Chain5 active DMFs4 inactive

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

DIPHARMA FRANCIS SRLAMITRIPTYLINE HYDROCHLORIDE

DMF 29081977

RL FINE CHEM PVT LTDAMITRIPTYLINE HYDROCHLORIDE

DMF 181112005

SUN PHARMACEUTICAL INDUSTRIES LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 195892006

VASUDHA PHARMA CHEM LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 196352006

MANKIND PHARMA LTDAMITRIPTYLINE HYDROCHLORIDE USP

DMF 335652019

KV PHARMACEUTICAL COInactiveAMITRIPTYLINE HYDROCHLORIDE

DMF 24131975

EGIS PHARMACEUTICALS PRIVATE LTDInactiveAMITRIPTYLINE HYDROCHLORIDE

DMF 70591987

MERIND LTDInactiveAMITRIPTYLINE HYDROCHLORIDE USP

DMF 110271994

WANBURY LTDInactiveAMITRIPTYLINE

DMF 181742005

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Aug 6, 2003	SUPPL -46	View Letter (PDF)
Mar 27, 2001	SUPPL -45	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 10MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.