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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Army
Boehringer Ingelheim
Fish and Richardson

Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205014

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NDA 205014 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 205014
Applicant:Mylan Institutional
Ingredient:naloxone hydrochloride
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205014
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 205014
Suppliers and Packaging for NDA: 205014
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE naloxone hydrochloride INJECTABLE;INJECTION 205014 ANDA Mylan Institutional LLC 67457-299 N 67457-299-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Jun 29, 2016TE:APRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Harvard Business School
Federal Trade Commission
Argus Health

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