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Serving leading biopharmaceutical companies globally:

Moodys
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Generated: October 17, 2017

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, 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 NDA: 070172

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 070172

Mechanism of ActionOpioid Antagonists

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 0409-1782-69 10 CARTRIDGE in 1 BOX (0409-1782-69) > 1 mL in 1 CARTRIDGE (0409-1782-03)
NALOXONE HYDROCHLORIDE
naloxone hydrochloride
INJECTABLE;INJECTION 070172 ANDA General Injectables & Vaccines, Inc 52584-782 52584-782-69 1 BOX in 1 BAG (52584-782-69) > 1 CARTRIDGE in 1 BOX > 1 mL in 1 CARTRIDGE

Summary 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 leading biopharmaceutical companies globally:

Queensland Health
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Federal Trade Commission
Farmers Insurance
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Citi
Novartis

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