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Last Updated: August 5, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 071717

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NDA 071717 describes FLURAZEPAM HYDROCHLORIDE, which is a drug marketed by Aurolife Pharma Llc, Halsey, Heritage Pharma, Hikma Intl Pharms, Hikma Pharms, Mylan Pharms Inc, Par Pharm, Purepac Pharm, Sun Pharm Industries, Superpharm, Usl Pharma, and Warner Chilcott, and is included in twenty-two NDAs. It is available from two 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. Two suppliers are listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.
Summary for 071717
Applicant:Aurolife Pharma Llc
Ingredient:flurazepam hydrochloride
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 071717

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Jul 31, 1991TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG
Approval Date:Jul 31, 1991TE:RLD:No

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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