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Details for New Drug Application (NDA): 204997

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NDA 204997 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Marsam Pharms Llc, Mylan Institutional, Intl Medication, Watson Labs, Hospira, Smith And Nephew, Eurohlth Intl Sarl, Solopak, Astrazeneca, Igi Labs Inc, Sun Pharm Inds Ltd, and Gavis Pharms, and is included in forty-five 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. Nine suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for NDA: 204997

Tradename:
NALOXONE HYDROCHLORIDE
Applicant:
Mylan Institutional
Ingredient:
naloxone hydrochloride
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 204997

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 204997

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE HYDROCHLORIDE
naloxone hydrochloride
INJECTABLE;INJECTION 204997 ANDA Mylan Institutional LLC 67457-292 67457-292-02 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-292-02) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-292-00)
NALOXONE HYDROCHLORIDE
naloxone hydrochloride
INJECTABLE;INJECTION 204997 ANDA Mylan Institutional LLC 67457-599 67457-599-02 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-599-02) > 1 mL in 1 VIAL, SINGLE-DOSE (67457-599-00)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.4MG/ML
Approval Date:Mar 6, 2014TE:APRLD:No


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