Assyro AI

Orange Book product · Generic (ANDA)

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Generic (ANDA)ANDA 040219DISCN MUTUAL PHARM

At a glance

Jan 22, 1998

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 22, 1998

    28 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Strength

500MG;5MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 040219

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

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.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.