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COLESEVELAM HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2018-10-05

Drug application

FDA Application #
ANDA209038
Application type
Abbreviated New Drug Application (Generic)
Brand name
COLESEVELAM HYDROCHLORIDE
Generic name
COLESEVELAM HCL
Active ingredients
COLESEVELAM HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ALKEM LABS LTD
Manufacturer
Ascend Laboratories, LLC
First approval
2018-10-05

Source

Authoritative
Drugs@FDA application overview
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