Assyro AI

Orange Book product · Generic (ANDA)

GABAPENTIN

GABAPENTIN

Generic (ANDA)ANDA 211313TE AB1RX STRIDES PHARMA

At a glance

Dec 20, 2024

Approved

Generic (ANDA)

Application

AB1

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 20, 2024

    1 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GABAPENTIN

Strength

100MG

Dosage form

TABLET

Route

ORAL

TE code

AB1

Application

ANDA 211313

Product number

003

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.