Assyro AI

Orange Book product · Generic (ANDA)

GABAPENTIN

GABAPENTIN

Generic (ANDA)ANDA 078782DISCN HIKMA PHARMS

At a glance

Jul 21, 2011

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 21, 2011

    15 yr 2 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GABAPENTIN

Strength

600MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 078782

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of GABAPENTIN

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.