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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Harvard Business School
Fish and Richardson
Baxter
Cantor Fitzgerald
Covington
Chinese Patent Office
Merck
AstraZeneca

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 072076

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NDA 072076 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 072076
Tradename:NALOXONE HYDROCHLORIDE
Applicant:Intl Medication
Ingredient:naloxone hydrochloride
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 072076
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 072076
Suppliers and Packaging for NDA: 072076
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072076 ANDA General Injectables & Vaccines, Inc. 52584-369 E 52584-369-01
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 072076 ANDA General Injectables & Vaccines, Inc. 52584-469 E 52584-469-00

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Mar 24, 1988TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Merck
McKinsey
Colorcon
US Army
Deloitte
McKesson
Argus Health
Cerilliant
Johnson and Johnson

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