Assyro AI

Orange Book product · Generic (ANDA)

SULFASALAZINE

SULFASALAZINE

Generic (ANDA)ANDA 088052DISCN WATSON LABS

At a glance

May 24, 1983

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    May 24, 1983

    43 yr 8 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SULFASALAZINE

Strength

500MG

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

TE code

Not listed

Application

ANDA 088052

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SULFASALAZINE

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.