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Orange Book product · Generic (ANDA)

DICLOFENAC POTASSIUM

DICLOFENAC POTASSIUM

Generic (ANDA)ANDA 213875TE ABRX AUROBINDO PHARMA LTD

At a glance

Oct 19, 2021

Approved

Generic (ANDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Oct 19, 2021

    4 yr 9 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DICLOFENAC POTASSIUM

Strength

25MG

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

ANDA 213875

Product number

001

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DICLOFENAC 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.