Orange Book product · Generic (ANDA)

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Generic (ANDA)ANDA 211023TE AARX WES PHARMA INC

View ACETAMINOPHEN; HYDROCODONE BITARTRATE family Open on FDA Orange Book

At a glance

Mar 08, 2019

Approved

Generic (ANDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Mar 08, 2019
7 yr 5 mo ago
Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; HYDROCODONE BITARTRATE

Strength

325MG/15ML;7.5MG/15ML

Dosage form

SOLUTION

Route

ORAL

TE code

Application

ANDA 211023

Product number

001

Marketing status

Reference listed drug (RLD)

Reference standard (RS)

Yes

Active-ingredient family

View full family

Generic (ANDA) of ACETAMINOPHEN; HYDROCODONE BITARTRATE

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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