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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 070427

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NDA 070427 describes PRAZEPAM, which is a drug marketed by Usl Pharma and is included in two NDAs. Additional details are available on the PRAZEPAM profile page.

The generic ingredient in PRAZEPAM is prazepam. There are four drug master file entries for this compound. Additional details are available on the prazepam profile page.

Summary for 070427

Tradename:	PRAZEPAM
Applicant:	Usl Pharma
Ingredient:	prazepam
Patents:	0

Medical Subject Heading (MeSH) Categories for 070427

Anti-Anxiety Agents
GABA Modulators

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	5MG
Approval Date:	Nov 6, 1987	TE:		RLD:	No

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