Assyro AI

Orange Book product · Generic (ANDA)

VALPROIC ACID

VALPROIC ACID

Generic (ANDA)ANDA 074060DISCN HIKMA

At a glance

Jan 13, 1995

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 13, 1995

    31 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

VALPROIC ACID

Strength

250MG/5ML

Dosage form

SYRUP

Route

ORAL

TE code

Not listed

Application

ANDA 074060

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.