Assyro AI

Orange Book product · Generic (ANDA)

CARBIDOPA AND LEVODOPA

CARBIDOPA; LEVODOPA

Generic (ANDA)ANDA 075091TE ABRX MYLAN

At a glance

Apr 21, 2000

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 21, 2000

    26 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

CARBIDOPA; LEVODOPA

Strength

25MG;100MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 075091

Product number

002

Marketing status

RX

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.