Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021524
Company: PROF DSPLS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
PREVANTICS MAXI SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (5.1ML) SWAB;TOPICAL Over-the-counter None Yes Yes
PREVANTICS SWAB CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (1ML) SWAB;TOPICAL Over-the-counter None Yes Yes
PREVANTICS SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (1.6ML) SWAB;TOPICAL Over-the-counter None Yes Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/03/2005 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021524lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021524ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021524s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/16/2019 SUPPL-20 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021524Orig1s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021524Orig1s020ltr.pdf
09/07/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021524Orig1s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021524Orig1s017ltr.pdf
07/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s015ltr.pdf
03/24/2014 SUPPL-14 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021524Orig1s014ltr.pdf
02/14/2018 SUPPL-12 Labeling-Container/Carton Labels, Efficacy-Labeling Change With Clinical Data Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021524Orig1s012ltr.pdf
05/17/2012 SUPPL-11 Labeling-Package Insert Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524Orig1s011ltr.pdf
03/01/2012 SUPPL-10 Labeling-Proprietary Name Change Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021524s010ltr.pdf
08/13/2009 SUPPL-8 Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

10/15/2007 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s004ltr.pdf
03/20/2007 SUPPL-3 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021524s003ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
01/16/2019 SUPPL-20 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021524Orig1s020lbl.pdf
09/07/2017 SUPPL-17 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021524Orig1s017lbl.pdf
07/25/2014 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s015lbl.pdf
03/24/2014 SUPPL-14 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021524Orig1s014lbl.pdf
10/15/2007 SUPPL-4 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s004lbl.pdf
03/20/2007 SUPPL-3 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021524s003lbl.pdf
06/03/2005 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021524lbl.pdf

PREVANTICS MAXI SWABSTICK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 3.15%;70% (5.1ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PREVANTICS MAXI SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (5.1ML) SWAB;TOPICAL Over-the-counter Yes 021524 PROF DSPLS

PREVANTICS SWAB

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 3.15%;70% (1ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PREVANTICS SWAB CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (1ML) SWAB;TOPICAL Over-the-counter Yes 021524 PROF DSPLS

PREVANTICS SWABSTICK

The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.

SWAB;TOPICAL; 3.15%;70% (1.6ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
PREVANTICS SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 3.15%;70% (1.6ML) SWAB;TOPICAL Over-the-counter Yes 021524 PROF DSPLS

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