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Generated: December 11, 2017

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, 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 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 070345

Tradename:1
Applicant:1
Ingredient:1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 070345

Ingredient-typeBenzodiazepines

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)

Summary for product number 001

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

Summary for product number 002

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


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