Orange Book product · Brand (NDA)

DURLAZA

ASPIRIN

Brand (NDA)NDA 200671DISCN HESP

View ASPIRIN family Open on FDA Orange Book

At a glance

Sep 04, 2015

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Sep 04, 2015
10 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

ASPIRIN

Strength

162.5MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

NDA 200671

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

VAZALOREBrand (NDA)
NDA 203697 · PLX PHARMA
2021
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAINBrand (NDA)
NDA 021317 · BAYER
2001
8-HOUR BAYERBrand (NDA)
NDA 016030 · BAYER
—

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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