Assyro AI

Orange Book product · Generic (ANDA)

ACETAMINOPHEN AND CODEINE PHOSPHATE

ACETAMINOPHEN; CODEINE PHOSPHATE

Generic (ANDA)ANDA 089481DISCN AM THERAP
View ACETAMINOPHEN; CODEINE PHOSPHATE familyOpen on FDA Orange Book

At a glance

Mar 03, 1987

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 03, 1987

    39 yr 10 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

ACETAMINOPHEN; CODEINE PHOSPHATE

Strength

300MG;15MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 089481

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; CODEINE PHOSPHATE

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.

Book a Demo