Assyro AI

Orange Book product · Generic (ANDA)

SEVELAMER CARBONATE

SEVELAMER CARBONATE

Generic (ANDA)ANDA 201513DISCN LUPIN

At a glance

Dec 23, 2021

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Dec 23, 2021

    4 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

SEVELAMER CARBONATE

Strength

2.4GM/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 201513

Product number

002

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of SEVELAMER CARBONATE

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.