Assyro AI

Orange Book product · Generic (ANDA)

GABAPENTIN

GABAPENTIN

Generic (ANDA)ANDA 218075TE AB2RX ANNORA PHARMA

At a glance

Feb 26, 2024

Approved

Generic (ANDA)

Application

AB2

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Feb 26, 2024

    2 yr 4 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GABAPENTIN

Strength

300MG

Dosage form

TABLET

Route

ORAL

TE code

AB2

Application

ANDA 218075

Product number

001

Marketing status

RX

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.