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Generated: January 19, 2019

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Details for New Drug Application (NDA): 205723

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NDA 205723 describes DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Alra, Anabolic, Barr, Elkins Sinn, Fosun Pharma, Halsey, Heather, Hikma Intl Pharms, Impax Labs, Ivax Sub Teva Pharms, Lannett, Lederle, LNK, Mk Labs, Mutual Pharm, Newtron Pharms, Nexgen Pharma Inc, Perrigo, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Superpharm, Teva, Valeant Pharm Intl, Vangard, Watson Labs, Whiteworth Town Plsn, Bundy, Cenci, Kv Pharm, Naska, Pharm Assoc, App Pharms, Bel Mar, Eurohlth Intl Sarl, Hospira, Lyphomed, Micro Labs, Mylan Institutional, Watson Labs Teva, West-ward Pharms Int, Wyeth Ayerst, Alpharma Us Pharms, Cumberland Swan, Hi Tech Pharma, Abraxis Pharm, Fresenius Kabi Usa, and Intl Medication, and is included in seventy-four NDAs. It is available from twenty-two suppliers. Additional details are available on the DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride. There are twenty-three drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride profile page.
Summary for 205723
Tradename:DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Micro Labs
Ingredient:diphenhydramine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 205723
Suppliers and Packaging for NDA: 205723
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride INJECTABLE;INJECTION 205723 ANDA Micro Labs Limited 42571-169 42571-169-55 10 AMPULE in 1 CARTON (42571-169-55) > 1 mL in 1 AMPULE (42571-169-54)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Aug 22, 2018TE:APRLD:No

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