Assyro AI

Orange Book product · Generic (ANDA)

CODEINE SULFATE

CODEINE SULFATE

Generic (ANDA)ANDA 203046TE ABRX LANNETT CO INC

At a glance

Jun 13, 2014

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 13, 2014

    12 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CODEINE SULFATE

Strength

15MG

Dosage form

TABLET

Route

ORAL

TE code

AB

Application

ANDA 203046

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CODEINE SULFATE

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.