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Generated: September 21, 2018

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Details for New Drug Application (NDA): 070172

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NDA 070172 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 sixteen 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 070172
Tradename:NALOXONE HYDROCHLORIDE
Applicant:Hospira
Ingredient:naloxone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070172
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 070172
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 HF Acquisition Co. LLC, DBA HealthFirst 51662-1238 51662-1238-1 1 mL in 1 CARTRIDGE (51662-1238-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Sep 24, 1986TE:APRLD:No

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