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NDA

DOXEPIN HYDROCHLORIDE | N017516 | PFIZER LABORATORIES DIV PFIZER 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 Chain4 active DMFs2 inactive

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

OLON SPADOXEPIN HYDROCHLORIDE

DMF 50251983

MSN LIFE SCIENCES PRIVATE LTDDOXEPIN HYDROCHLORIDE USP

DMF 335592019

R L FINE CHEM PVT LTDDOXEPIN HYDROCHLORIDE

DMF 344382020

RAKS PHARMA PVT LTDDOXEPIN HYDROCHLORIDE USP

DMF 350172020

BOEHRINGER MANNHEIM GMBHInactiveDOXEPIN

DMF 24101975

GANES CHEMICALS INC PENNSVILLE DIVInactiveDOXEPIN HYDROCHLORIDE

DMF 68561987

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 10MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.