Assyro AI

Orange Book product · Generic (ANDA)

CARVEDILOL PHOSPHATE

CARVEDILOL PHOSPHATE

Generic (ANDA)ANDA 204717TE ABRX IMPAX LABS INC

At a glance

May 07, 2018

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 07, 2018

    8 yr 3 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARVEDILOL PHOSPHATE

Strength

10MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 204717

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARVEDILOL 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.