Assyro AI

Orange Book product · Generic (ANDA)

ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Generic (ANDA)ANDA 040688DISCN WRASER PHARMS LLC

At a glance

Apr 03, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2007

    19 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE

Strength

356.4MG;30MG;16MG

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 040688

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; CAFFEINE; DIHYDROCODEINE 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.

Agent CTA Background

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