← FDA DRUG APPROVALS

FDA NDA · NDA021555

CHLORAPREP ONE-STEP

chlorhexidine gluconate and isopropyl alcohol

Sponsor: BECTON DICKINSON CO

APPLICATION
NDA021555
TYPE
NDA
ORIGINAL APPROVAL
2002-10-07
LATEST ACTION
2023-08-30
ROUTE
TOPICAL
DOSAGE FORM
SWAB
MARKETING STATUS
Over-the-counter

Products

CHLORAPREP TRIPLE SWABSTICK · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (5.25ML) · SWAB · TOPICAL
CHLORAPREP ONE-STEP SEPP · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (0.67ML) · SWAB · TOPICAL
CHLORAPREP SINGLE SWABSTICK · ReferenceOver-the-counter
CHLORHEXIDINE GLUCONATE 2%, ISOPROPYL ALCOHOL 70% (1.75ML) · SWAB · TOPICAL

Approval history

2023-08-30Manufacturing (CMC) · Supplement 28 — Label ↗AP
2017-12-22Manufacturing (CMC) · Supplement 20 — Label ↗AP
2017-09-12Labeling · Supplement 24 · standard — Letter ↗AP
2014-06-30Labeling · Supplement 19 · standard — Label ↗AP
2013-10-10Labeling · Supplement 18 · standard — Label ↗AP
2012-08-16Labeling · Supplement 17 · standard — Label ↗AP
2012-08-16Labeling · Supplement 16 · standard — Letter ↗AP
2010-07-20Labeling · Supplement 15 · standard — Letter ↗AP
2010-03-02Labeling · Supplement 14 · standardAP
2009-06-10Manufacturing (CMC) · Supplement 3 — Letter ↗AP
2007-08-09Manufacturing (CMC) · Supplement 9 — Label ↗AP
2006-12-20Labeling · Supplement 7 · standard — Letter ↗AP
2005-12-27Manufacturing (CMC) · Supplement 5 — Letter ↗AP
2005-05-10Manufacturing (CMC) · Supplement 1 · standard — Letter ↗AP
2002-10-07Type 3 - New Dosage Form · 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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