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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 071811

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NDA 071811 describes NALOXONE HYDROCHLORIDE, which is a drug marketed by Abraxis Pharm, Accord Hlthcare, Astrazeneca, Baxter Hlthcare Corp, Bpi Labs, Chartwell Rx, Dr Reddys, Endo Operations, Eugia Pharma, Fresenius Kabi Usa, Hikma, 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 sixty-eight NDAs. It is available from thirty-six suppliers. There are eighteen patents protecting this drug. 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. Three suppliers are listed for this compound. Additional details are available on the naloxone hydrochloride; pentazocine hydrochloride profile page.

Summary for 071811

Tradename:	NALOXONE HYDROCHLORIDE
Applicant:	Marsam Pharms Llc
Ingredient:	naloxone hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 071811

Narcotic Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	0.4MG/ML
Approval Date:	Jul 19, 1988	TE:		RLD:	No

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