Assyro AI

Orange Book product · Generic (ANDA)

RALTEGRAVIR POTASSIUM

RALTEGRAVIR POTASSIUM

Generic (ANDA)ANDA 203540DISCN HETERO LABS LTD III

At a glance

Dec 19, 2024

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 19, 2024

    1 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

RALTEGRAVIR POTASSIUM

Strength

EQ 400MG BASE

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

ANDA 203540

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of RALTEGRAVIR POTASSIUM

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.