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Generated: October 19, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091205

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NDA 091205 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Barr, Sandoz, Sun Pharma Global, Mallinckrodt, and Elite Labs, and is included in seven NDAs. It is available from fourteen suppliers. Additional details are available on the NALTREXONE HYDROCHLORIDE profile page.

The generic ingredient in NALTREXONE HYDROCHLORIDE is naltrexone hydrochloride. There are nineteen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the naltrexone hydrochloride profile page.

Summary for NDA: 091205

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidotes, Deterrents, and Toxicologic Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 091205

Mechanism of ActionOpioid Antagonists

Suppliers and Packaging for NDA: 091205

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL 091205 ANDA Accord Healthcare, Inc. 16729-081 16729-081-01 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01)
NALTREXONE HYDROCHLORIDE
naltrexone hydrochloride
TABLET;ORAL 091205 ANDA Accord Healthcare, Inc. 16729-081 16729-081-10 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:Aug 17, 2011TE:ABRLD:No


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