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Orange Book product · Generic (ANDA)

OXYCODONE AND ACETAMINOPHEN

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Generic (ANDA)ANDA 211499RX ABHAI LLC
View ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Dec 31, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 31, 2018

    7 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

Strength

325MG/5ML;5MG/5ML

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

ANDA 211499

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

Yes

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

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