Assyro AI

Orange Book product · Generic (ANDA)

PARCOPA

CARBIDOPA; LEVODOPA

Generic (ANDA)ANDA 076699DISCN UCB INC

At a glance

Aug 27, 2004

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Aug 27, 2004

    22 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARBIDOPA; LEVODOPA

Strength

10MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

ANDA 076699

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of CARBIDOPA; LEVODOPA

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.