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FDA NDA · NDA200671

DURLAZA

Sponsor: HESP

APPLICATION
NDA200671
TYPE
NDA
ORIGINAL APPROVAL
2015-09-04
LATEST ACTION
2015-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

DURLAZA · ReferenceDiscontinued
ASPIRIN 162.5MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2015-09-30Labeling · Supplement 2 · standard — Label ↗AP
2015-09-15Labeling · Supplement 1 · standard — Label ↗AP
2015-09-04Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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