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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
US Department of Justice
Cantor Fitzgerald
Daiichi Sankyo

Generated: June 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070257

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NDA 070257 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Marsam Pharms Llc, Mylan Institutional, Intl Medication, Watson Labs, Hospira, Akorn, Smith And Nephew, Eurohlth Intl Sarl, Solopak, Astrazeneca, Igi Labs Inc, Sun Pharm Inds Ltd, and Gavis Pharms, and is included in forty-seven NDAs. It is available from eleven 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. Nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for NDA: 070257

Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070257

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 070257

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naloxone hydrochloride
INJECTABLE;INJECTION 070257 ANDA Hospira, Inc. 0409-1219 0409-1219-01 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1219-01) > 10 mL in 1 VIAL, MULTI-DOSE
naloxone hydrochloride
INJECTABLE;INJECTION 070257 ANDA Hospira, Inc. 0409-1219 0409-1219-25 1 VIAL, MULTI-DOSE in 1 CARTON (0409-1219-25) > 10 mL in 1 VIAL, MULTI-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Jan 7, 1987TE:APRLD:No

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Serving 500+ biopharmaceutical companies globally:

Argus Health
Boehringer Ingelheim
Farmers Insurance
Johnson and Johnson
Chinese Patent Office

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