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. One supplier is listed for this compound. Additional details are available on the flurazepam hydrochloride profile page.

Summary for 016721

Tradename:	DALMANE
Applicant:	Valeant Pharm Intl
Ingredient:	flurazepam hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 016721

Anti-Anxiety Agents
GABA Modulators
Hypnotics and Sedatives

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	15MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 016721

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-001	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
Valeant Pharm Intl	DALMANE	flurazepam hydrochloride	CAPSULE;ORAL	016721-002	Approved Prior to Jan 1, 1982	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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