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US Department of Justice
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071551

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NDA 071551 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Aurolife Pharma Llc, Halsey, Hikma Intl Pharms, Hikma Pharms, Mylan Pharms Inc, Par Pharm, Purepac Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, Warner Chilcott, and Watson Labs, and is included in twenty-two NDAs. It is available from seven suppliers. Additional details are available on the FLURAZEPAM HYDROCHLORIDE profile page.

The generic ingredient in FLURAZEPAM HYDROCHLORIDE 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 071551
Applicant:Purepac Pharm
Ingredient:flurazepam hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 071551

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Sep 9, 1987TE:RLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
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Fish and Richardson

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