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DIPHENHYDRAMINE HYDROCHLORIDE

ANDA

DIPHENHYDRAMINE HYDROCHLORIDE | A040466 | APP PHARMACEUTICALS LLC

1 strength0 unique patents0 unique exclusivities

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
Apr 9, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: May 28, 2002

No patent or exclusivity listings for this strength.