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Orange Book product · Generic (ANDA)

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Generic (ANDA)ANDA 077381OTC DR REDDYS LABS INC

At a glance

Sep 27, 2006

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Sep 27, 2006

    20 yr ago

  2. Today

Pharmaceutical detail

Active ingredient

NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE

Strength

220MG;120MG

Dosage form

TABLET, EXTENDED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 077381

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; PSEUDOEPHEDRINE HYDROCHLORIDE

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.