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Serving hundreds of leading biopharmaceutical companies globally:

Daiichi Sankyo
Deloitte
Queensland Health
UBS
US Army
Cerilliant
Mallinckrodt
Dow
Teva

Generated: April 26, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070172

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NDA 070172 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Akorn, Astrazeneca, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Gavis Pharms, and Sun Pharm Inds Ltd, and is included in forty-nine NDAs. It is available from thirteen suppliers. Additional details are available on the NALOXONE HYDROCHLORIDE profile page.

The generic ingredient in NALOXONE HYDROCHLORIDE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
Summary for 070172
Tradename:NALOXONE HYDROCHLORIDE
Applicant:Hospira
Ingredient:naloxone hydrochloride
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 070172
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 070172
Suppliers and Packaging for NDA: 070172
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070172 ANDA Hospira, Inc. 0409-1782 N 0409-1782-69
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 070172 ANDA General Injectables & Vaccines, Inc 52584-782 N 52584-782-69

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Sep 24, 1986TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Fuji
Julphar
Daiichi Sankyo
US Department of Justice
Mallinckrodt
Cipla
Covington
Cerilliant
Cantor Fitzgerald

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