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BENADRYL PRESERVATIVE FREE

NDA

DIPHENHYDRAMINE HYDROCHLORIDE | N009486 | MCNEIL CONSUMER HEALTHCARE

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 DMFs5 inactive

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

BEIJING TAIYANG PHARMACEUTICAL INDUSTRY CO LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 197372006

WANBURY LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 205722007

SUPRIYA LIFESCIENCE LTDDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 351742020

GLAND PHARMA LTDDIPHENHYDRAMINE HYDROCHLORIDE

DMF 359532021

S. S. PHARMACHEMDIPHENHYDRAMINE

DMF 421072025

GANES CHEMICALS INC PENNSVILLE DIVInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 12371968

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 56531984

UNICHEM LABORATORIES LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE

DMF 76611988

KAMUD DRUGS PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 226012009

SOUVIN PHARMACEUTICAL I PVT LTDInactiveDIPHENHYDRAMINE HYDROCHLORIDE USP

DMF 267722012

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 5, 2003	SUPPL -28	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.