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Details for New Drug Application (NDA): 016721

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NDA 016721 describes DALMANE, which is a drug marketed by Valeant Pharm Intl and is included in one NDA. Additional details are available on the DALMANE profile page.

The generic ingredient in DALMANE is flurazepam hydrochloride. There are four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

Summary for NDA: 016721

Valeant Pharm Intl
flurazepam hydrochloride

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength15MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:CAPSULE;ORALStrength30MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Expired Orange Book Patents for NDA: 016721

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Valeant Pharm Intl
flurazepam hydrochloride
CAPSULE;ORAL016721-001Approved Prior to Jan 1, 19824,316,897<subscribe>
Valeant Pharm Intl
flurazepam hydrochloride
CAPSULE;ORAL016721-002Approved Prior to Jan 1, 19824,316,897<subscribe>
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