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Last Updated: July 3, 2020

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Details for New Drug Application (NDA): 070299

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NDA 070299 describes NALOXONE, which is a drug marketed by West-ward Pharms Int, Wyeth Ayerst, Abraxis Pharm, Akorn, Astrazeneca, Aurobindo Pharma Ltd, Dr Reddys, Eurohlth Intl Sarl, Hospira, Igi Labs Inc, Intl Medication, Marsam Pharms Llc, Mylan Institutional, Par Sterile Products, Smith And Nephew, Solopak, Somerset Theraps Llc, Virtus Pharms, Watson Labs, Teva Pharms Usa, Lupin, and Sun Pharm Inds Ltd, and is included in sixty-two NDAs. It is available from one supplier. Additional details are available on the NALOXONE profile page.

The generic ingredient in NALOXONE is naloxone hydrochloride; pentazocine hydrochloride. There are twelve drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.
Summary for 070299
Applicant:West-ward Pharms Int
Ingredient:naloxone hydrochloride
Formulation / Manufacturing:see details
Pharmacology for NDA: 070299
Mechanism of ActionOpioid Antagonists
Medical Subject Heading (MeSH) Categories for 070299
Suppliers and Packaging for NDA: 070299
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALOXONE naloxone hydrochloride INJECTABLE;INJECTION 070299 ANDA Hikma Pharmaceuticals USA Inc. 0641-6132 0641-6132-25 25 VIAL in 1 CARTON (0641-6132-25) > 1 mL in 1 VIAL (0641-6132-01)

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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