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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Fuji
Queensland Health
Citi
UBS
Moodys
Teva
Express Scripts

Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 016721

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NDA 016721 describes DALMANE, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. Additional details are available on the DALMANE profile page.

The generic ingredient in DALMANE is flurazepam hydrochloride. There are four drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.
Summary for 016721
Tradename:DALMANE
Applicant:Valeant Pharm Intl
Ingredient:flurazepam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 016721

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Expired US Patents for NDA 016721

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-001 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharm Intl DALMANE flurazepam hydrochloride CAPSULE;ORAL 016721-002 Approved Prior to Jan 1, 1982 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Mallinckrodt
Chubb
Harvard Business School
US Army
Healthtrust
Argus Health
AstraZeneca
Baxter

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