Assyro AI

Orange Book product · Generic (ANDA)

KALEXATE

SODIUM POLYSTYRENE SULFONATE

Generic (ANDA)ANDA 040905RX KVK TECH

At a glance

Apr 03, 2015

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Apr 03, 2015

    11 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SODIUM POLYSTYRENE SULFONATE

Strength

15GM/BOT

Dosage form

POWDER

Route

ORAL, RECTAL

TE code

Not listed

Application

ANDA 040905

Product number

002

Marketing status

RX

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SODIUM POLYSTYRENE SULFONATE

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.