Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Covington
McKesson
Express Scripts
Teva
Federal Trade Commission
Colorcon

Generated: September 23, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075274

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NDA 075274 describes NALTREXONE HYDROCHLORIDE, which is a drug marketed by Accord Hlthcare, Apotex Inc, Barr, Elite Labs, Fosun Pharma, Specgx Llc, and Sun Pharm, 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 075274
Tradename:NALTREXONE HYDROCHLORIDE
Applicant:Elite Labs
Ingredient:naltrexone hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075274
Mechanism of ActionOpioid Antagonists
Suppliers and Packaging for NDA: 075274
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274 ANDA AvKARE, Inc. 42291-632 42291-632-30 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30)
NALTREXONE HYDROCHLORIDE naltrexone hydrochloride TABLET;ORAL 075274 ANDA A-S Medication Solutions 50090-2866 50090-2866-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-2866-0)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength50MG
Approval Date:May 26, 1999TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
Chinese Patent Office
Fish and Richardson
Johnson and Johnson
Merck
Julphar

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