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FDA NDA · NDA020610

COLAZAL

Sponsor: VALEANT PHARMS INTL

APPLICATION
NDA020610
TYPE
NDA
ORIGINAL APPROVAL
2000-07-18
LATEST ACTION
2023-10-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

COLAZAL · ReferencePrescription
BALSALAZIDE DISODIUM 750MG · CAPSULE · ORAL

Approval history

2023-10-24Labeling · Supplement 26 · standard — Label ↗AP
2022-11-16Labeling · Supplement 25 · standard — Letter ↗AP
2021-11-01Labeling · Supplement 24 · standard — Letter ↗AP
2020-10-01Labeling · Supplement 23 · standard — Letter ↗AP
2019-06-21Labeling · Supplement 21 · standard — Letter ↗AP
2015-01-05Manufacturing (CMC) · Supplement 20 · standardAP
2014-03-05Manufacturing (CMC) · Supplement 19 · standardAP
2008-07-09Labeling · Supplement 18 · standard — Letter ↗AP
2007-11-02Labeling · Supplement 17 · standard — Label ↗AP
2006-12-20Efficacy · Supplement 16 · priority — Pediatric Clinical Pharmacology Review ↗AP
2006-09-21Labeling · Supplement 14 · standard — Label ↗AP
2006-03-10Manufacturing (CMC) · Supplement 13 · standard — Letter ↗AP
2002-06-18Labeling · Supplement 1 · standard — Letter ↗AP
2002-02-07Manufacturing (CMC) · Supplement 2 · standardAP
2000-07-18Type 1 - New Molecular Entity · Original · standard — Pediatric Written Request ↗AP
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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