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FDA NDA · NDA020222

COLESTID

colestipol hydrochloride

Sponsor: PFIZER

APPLICATION
NDA020222
TYPE
NDA
ORIGINAL APPROVAL
1994-07-19
LATEST ACTION
2017-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

COLESTID · ReferencePrescription
COLESTIPOL HYDROCHLORIDE 1GM · TABLET · ORAL

Approval history

2017-05-25Labeling · Supplement 6 · standard — Label ↗AP
2014-05-22Labeling · Supplement 5 · standard — Label ↗AP
2002-04-12Manufacturing (CMC) · Supplement 2 · priorityAP
1995-09-22Labeling · Supplement 1 · standardAP
1994-07-19Type 3 - New Dosage Form · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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