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COLESEVELAM HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2019-05-06

Drug application

FDA Application #

ANDA210316

Application type

Abbreviated New Drug Application (Generic)

Brand name

COLESEVELAM HYDROCHLORIDE

Generic name

COLESEVELAM HYDROCHLORIDE

Active ingredients

COLESEVELAM HYDROCHLORIDE

Dosage form

FOR SUSPENSION

Route

ORAL

Marketing status

Prescription

Sponsor

ALKEM LABS LTD

Manufacturer

Ascend Laboratories, LLC

First approval

2019-05-06

Source

Authoritative

Drugs@FDA application overview

Machine

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