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Orange Book product · Generic (ANDA)

NAPROXEN SODIUM

NAPROXEN SODIUM

Generic (ANDA)ANDA 208363OTC PURACAP PHARM LLC
View NAPROXEN SODIUM familyOpen on FDA Orange Book

At a glance

Mar 15, 2018

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 15, 2018

    8 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NAPROXEN SODIUM

Strength

EQ 200MG BASE

Dosage form

CAPSULE

Route

ORAL

TE code

Not listed

Application

ANDA 208363

Product number

001

Marketing status

OTC

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of NAPROXEN 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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