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Last Updated: March 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 are twenty-two drug master file entries 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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