Assyro AI

Orange Book product · Generic (ANDA)

CARVEDILOL

CARVEDILOL

Generic (ANDA)ANDA 077346DISCN SUN PHARM INDS INC

At a glance

Sep 05, 2007

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 05, 2007

    19 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARVEDILOL

Strength

3.125MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 077346

Product number

004

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARVEDILOL

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.