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FDA NDA · NDA022067

FLO-PRED

Sponsor: SUN PHARMA CANADA

APPLICATION
NDA022067
TYPE
NDA
ORIGINAL APPROVAL
2008-01-17
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

FLO-PREDDiscontinued
PREDNISOLONE ACETATE EQ 5MG BASE/5ML · SUSPENSION · ORAL
FLO-PREDDiscontinued
PREDNISOLONE ACETATE EQ 15MG BASE/5ML · SUSPENSION · ORAL

Approval history

2024-06-05Labeling · Supplement 15 · standard — Label ↗AP
2021-07-15Labeling · Supplement 14 · standard — Letter ↗AP
2014-10-03Manufacturing (CMC) · Supplement 12 · standardAP
2014-09-29Manufacturing (CMC) · Supplement 11 · standardAP
2014-02-28Manufacturing (CMC) · Supplement 10 · standardAP
2011-06-14Labeling · Supplement 7 · unknown — Letter ↗AP
2010-05-06Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2008-10-03Manufacturing (CMC) · Supplement 2 — Label ↗AP
2008-06-27Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2008-01-17Type 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.

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