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Orange Book product · Brand (NDA)

PERCODAN

ASPIRIN; OXYCODONE HYDROCHLORIDE

Brand (NDA)NDA 007337DISCN ENDO OPERATIONS
View ASPIRIN; OXYCODONE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Aug 05, 2005

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 05, 2005

    21 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ASPIRIN; OXYCODONE HYDROCHLORIDE

Strength

325MG;4.8355MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 007337

Product number

007

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

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.

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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