Orange Book product · Brand (NDA)

WELCHOL

COLESEVELAM HYDROCHLORIDE

Brand (NDA)NDA 022362TE ABRX COSETTE

View COLESEVELAM HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Oct 02, 2009

Approved

Brand (NDA)

Application

TE code

None

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Oct 02, 2009
16 yr 11 mo ago
Today

Pharmaceutical detail

Active ingredient

COLESEVELAM HYDROCHLORIDE

Strength

3.75GM/PACKET

Dosage form

FOR SUSPENSION

Route

ORAL

TE code

Application

NDA 022362

Product number

002

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

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