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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 070299


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NDA 070299 describes NALOXONE, which is a drug marketed by Hikma, Wyeth Ayerst, Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hospira, Igi Labs Inc, Intl Medication, Mankind Pharma, Marsam Pharms Llc, Mylan Institutional, Mylan Labs Ltd, Par Sterile Products, Rising, Smith And Nephew, Solopak, Somerset Theraps Llc, Watson Labs, Amneal, Padagis Israel, Teva Pharms Usa, Kaleo Inc, Lupin, and Sun Pharm Inds Ltd, and is included in seventy-five NDAs. It is available from three suppliers. There are eighteen patents protecting this drug. 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
Tradename:NALOXONE
Applicant:Hikma
Ingredient:naloxone hydrochloride
Patents:0
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)
NALOXONE naloxone hydrochloride INJECTABLE;INJECTION 070299 ANDA Hikma Pharmaceuticals USA Inc. 0641-6260 0641-6260-25 25 VIAL in 1 CARTON (0641-6260-25) / 1 mL in 1 VIAL (0641-6260-01)

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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