Assyro AI

Orange Book product · Generic (ANDA)

VALPROIC ACID

VALPROIC ACID

Generic (ANDA)ANDA 070868DISCN PHARMOBEDIENT CNSLTG

At a glance

Jul 01, 1986

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 01, 1986

    40 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VALPROIC ACID

Strength

250MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 070868

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of VALPROIC ACID

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.