Assyro AI

Orange Book product · Generic (ANDA)

PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Generic (ANDA)ANDA 208175TE ABRX DR REDDYS LABS SA

At a glance

Jun 12, 2025

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 12, 2025

    1 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Strength

EQ 7.5MG BASE;46MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

AB

Application

ANDA 208175

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

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.