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FDA NDA · NDA021586

3M DURAPREP SURGICAL

iodine povacrylex and isopropyl alcohol

Sponsor: SOLVENTUM

APPLICATION
NDA021586
TYPE
NDA
ORIGINAL APPROVAL
2006-09-29
LATEST ACTION
2015-06-08
ROUTE
TOPICAL
DOSAGE FORM
SPONGE
MARKETING STATUS
Over-the-counter

Products

DURAPREP · ReferenceOver-the-counter
IODINE POVACRYLEX EQ 0.7% IODINE, ISOPROPYL ALCOHOL 74% (26ML) · SPONGE · TOPICAL
DURAPREP · ReferenceOver-the-counter
IODINE POVACRYLEX EQ 0.7% IODINE, ISOPROPYL ALCOHOL 74% (6ML) · SPONGE · TOPICAL

Approval history

2015-06-08Labeling · Supplement 5 · standard — Label ↗AP
2013-07-10Manufacturing (CMC) · Supplement 4 · standardAP
2013-02-20Manufacturing (CMC) · Supplement 3 · standardAP
2010-03-11Labeling · Supplement 2 · unknown — Letter ↗AP
2006-09-29Type 4 - New Combination · Original · standard — Letter ↗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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