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US Department of Justice
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Generated: November 17, 2017

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Details for New Drug Application (NDA): 071809

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NDA 071809 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Watson Labs, Hikma Intl Pharms, Halsey, Hikma Pharms, Aurolife Pharma Llc, Purepac Pharm, Par Pharm, Mylan Pharms Inc, Sun Pharm Inds, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-two NDAs. It is available from eight 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. Eight suppliers are listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

Summary for 071809

Formulation / Manufacturing:see details

Medical Subject Heading (MeSH) Categories for 071809

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Jan 7, 1988TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Fish and Richardson
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Chinese Patent Office
Johnson and Johnson

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