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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Queensland Health
US Department of Justice
Harvard Business School

Generated: November 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070256

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NDA 070256 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Marsam Pharms Llc, Mylan Institutional, Intl Medication, Somerset Theraps Llc, 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-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. Eight suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for 070256

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

Pharmacology for NDA: 070256

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 070256

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
naloxone hydrochloride
INJECTABLE;INJECTION 070256 ANDA Hospira, Inc. 0409-1215 0409-1215-01 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-01) > 1 mL in 1 VIAL, SINGLE-DOSE
naloxone hydrochloride
INJECTABLE;INJECTION 070256 ANDA Hospira, Inc. 0409-1215 0409-1215-25 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-1215-25) > 1 mL in 1 VIAL, SINGLE-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 leading biopharmaceutical companies globally:

Farmers Insurance
Johnson and Johnson
Harvard Business School
Queensland Health
US Army
Federal Trade Commission
Boehringer Ingelheim

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