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Last Updated: January 29, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070345

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NDA 070345 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 070345
Tradename:FLURAZEPAM HYDROCHLORIDE
Applicant:Mylan Pharms Inc
Ingredient:flurazepam hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070345
Medical Subject Heading (MeSH) Categories for 070345
Suppliers and Packaging for NDA: 070345
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070345 ANDA Mylan Pharmaceuticals Inc. 0378-4415 0378-4415-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4415-01)
FLURAZEPAM HYDROCHLORIDE flurazepam hydrochloride CAPSULE;ORAL 070345 ANDA Mylan Pharmaceuticals Inc. 0378-4430 0378-4430-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-4430-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength30MG
Approval Date:Nov 27, 1985TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength15MG
Approval Date:Nov 27, 1985TE:RLD:No

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