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FDA NDA · NDA020832

CHLORAPREP ONE-STEP

chlorhexidine gluconate and isopropyl alcohol

Sponsor: BECTON DICKINSON CO

APPLICATION
NDA020832
TYPE
NDA
ORIGINAL APPROVAL
2000-07-14
LATEST ACTION
2019-04-03
ROUTE
TOPICAL
DOSAGE FORM
SPONGE
MARKETING STATUS
Over-the-counter

Products

CHLORAPREP ONE-STEP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (1ML) · SPONGE · TOPICAL
CHLORAPREP ONE-STEP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (26ML) · SPONGE · TOPICAL
CHLORAPREP ONE-STEP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (10.5ML) · SPONGE · TOPICAL
CHLORAPREP WITH TINT · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (26ML) · SPONGE · TOPICAL
CHLORAPREP WITH TINT · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (3ML) · SPONGE · TOPICAL
CHLORAPREP WITH TINT · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (10.5ML) · SPONGE · TOPICAL
CHLORAPREP ONE-STEP FREPP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (1.5ML) · SPONGE · TOPICAL
CHLORAPREP ONE-STEP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (3ML) · SPONGE · TOPICAL

Approval history

2019-04-03Manufacturing (CMC) · Supplement 38AP
2019-04-03Manufacturing (CMC) · Supplement 36 — Label ↗AP
2017-09-12Labeling · Supplement 42 · standard — Letter ↗AP
2016-06-07Manufacturing (CMC) · Supplement 37 · standardAP
2015-06-09Manufacturing (CMC) · Supplement 35 · standardAP
2014-06-30Labeling · Supplement 34 · standard — Label ↗AP
2014-02-12Manufacturing (CMC) · Supplement 33 · standardAP
2013-10-10Labeling · Supplement 31 · standard — Label ↗AP
2012-12-27Manufacturing (CMC) · Supplement 29 · standard — Letter ↗AP
2012-08-16Labeling · Supplement 27 · standard — Letter ↗AP
2012-08-16Labeling · Supplement 28 · standard — Letter ↗AP
2012-08-16Labeling · Supplement 30 · standard — Label ↗AP
2010-07-20Labeling · Supplement 26 · unknown — Letter ↗AP
2010-03-03Labeling · Supplement 25 · unknown — Letter ↗AP
2008-10-23Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2008-06-03Manufacturing (CMC) · Supplement 14 — Letter ↗AP
2007-05-09Labeling · Supplement 18 · standard — Label ↗AP
2006-12-08Labeling · Supplement 12 · standard — Letter ↗AP
2006-11-21Manufacturing (CMC) · Supplement 15 — Letter ↗AP
2006-10-11Labeling · Supplement 16 · standard — Label ↗AP
2006-10-10Manufacturing (CMC) · Supplement 13 — Letter ↗AP
2006-04-03Manufacturing (CMC) · Supplement 10 · standard — Letter ↗AP
2005-12-27Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP
2005-05-03Manufacturing (CMC) · Supplement 8 · standard — Label ↗AP
2004-07-07Labeling · Supplement 7 · standard — Letter ↗AP
2004-06-10Labeling · Supplement 6 · standard — Other ↗AP
2003-08-20Manufacturing (CMC) · Supplement 4 · standard — Letter ↗AP
2002-04-26Manufacturing (CMC) · Supplement 2 · standard — Letter ↗AP
2001-11-27Manufacturing (CMC) · Supplement 1 · standardAP
2000-07-14Type 4 - New Combination · Original · standard — Review ↗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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