Last Updated: September 29, 2026

Details for New Drug Application (NDA): 200671

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NDA 200671 describes DURLAZA, which is a drug marketed by Hesp and is included in one NDA. Additional details are available on the DURLAZA profile page.

The generic ingredient in DURLAZA is aspirin. There is one drug master file entry for this compound. Additional details are available on the aspirin profile page.

Summary for 200671

Tradename:	DURLAZA
Applicant:	Hesp
Ingredient:	aspirin
Patents:	0

Medical Subject Heading (MeSH) Categories for 200671

Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Cyclooxygenase Inhibitors
Fibrinolytic Agents
Platelet Aggregation Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	162.5MG
Approval Date:	Sep 4, 2015	TE:		RLD:	Yes

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