← FDA DRUG APPROVALS

FDA NDA · NDA022205

GIAZO

Sponsor: VALEANT PHARMS INTL

APPLICATION
NDA022205
TYPE
NDA
ORIGINAL APPROVAL
2012-02-03
LATEST ACTION
2021-11-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

GIAZO · ReferenceDiscontinued
BALSALAZIDE DISODIUM 1.1GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2021-11-01Labeling · Supplement 5 · standard — Letter ↗AP
2020-10-01Labeling · Supplement 4 · standard — Letter ↗AP
2020-01-07Labeling · Supplement 3 · standard — Letter ↗AP
2015-01-05Manufacturing (CMC) · Supplement 2 · priorityAP
2013-12-16Labeling · Supplement 1 · standard — Letter ↗AP
2012-02-03Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →