Assyro AI

Orange Book product · Generic (ANDA)

GABAPENTIN

GABAPENTIN

Generic (ANDA)ANDA 075477TE ABRX CSPC OUYI

At a glance

Mar 23, 2005

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 23, 2005

    21 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

GABAPENTIN

Strength

100MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 075477

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.