Assyro AI

Orange Book product · Brand (NDA)

ALEVE

NAPROXEN SODIUM

Brand (NDA)NDA 020204OTC BAYER
View NAPROXEN SODIUM familyOpen on FDA Orange Book

At a glance

Jan 11, 1994

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 11, 1994

    32 yr 11 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

NAPROXEN SODIUM

Strength

220MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 020204

Product number

002

Marketing status

OTC

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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