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Orange Book product · Generic (ANDA)

DICLOFENAC SODIUM

DICLOFENAC SODIUM

Generic (ANDA)ANDA 208786DISCN RISING
View DICLOFENAC SODIUM familyOpen on FDA Orange Book

At a glance

Jun 18, 2019

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jun 18, 2019

    7 yr 1 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

DICLOFENAC SODIUM

Strength

37.5MG/ML (37.5MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

ANDA 208786

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of DICLOFENAC SODIUM

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

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