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Orange Book product · Generic (ANDA)

COLESEVELAM HYDROCHLORIDE

COLESEVELAM HYDROCHLORIDE

Generic (ANDA)ANDA 212886DISCN IMPAX
View COLESEVELAM HYDROCHLORIDE familyOpen on FDA Orange Book

At a glance

Jan 18, 2023

Approved

Generic (ANDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jan 18, 2023

    3 yr 6 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

COLESEVELAM HYDROCHLORIDE

Strength

3.75GM/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Not listed

Application

ANDA 212886

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

Generic (ANDA) of COLESEVELAM 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.

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