CHLORAPREP ONE-STEP از شرکت BECTON DICKINSON CO

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

CHLORAPREP ONE-STEP از شرکت BECTON DICKINSON CO

New Drug Application (NDA): 020832

Company: BECTON DICKINSON CO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP ONE-STEP FREPP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1.5ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;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
07/14/2000 ORIG-1 Approval

Type 4 – New Combination

STANDARD

Letter (PDF)

Review

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20832ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-832_CHLORAPREP.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2017 SUPPL-42 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020832Orig1s042lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020832Orig1s042ltr.pdf

04/03/2019 SUPPL-38 Manufacturing (CMC)-Control

Label is not available on this site.

06/07/2016 SUPPL-37 Manufacturing (CMC)

Label is not available on this site.

04/03/2019 SUPPL-36 Manufacturing (CMC)-Manufacturing Process

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020832Orig1s036_REPLACEMENT_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020832Orig1s036_REPLACEMENT_ltr.pdf

06/09/2015 SUPPL-35 Manufacturing (CMC)

Label is not available on this site.

06/30/2014 SUPPL-34 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020832Orig1s034,021555Orig1s019ltr.pdf

02/12/2014 SUPPL-33 Manufacturing (CMC)

Label is not available on this site.

10/10/2013 SUPPL-31 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020832Orig1s031,021555Orig1s018ltr.pdf

08/16/2012 SUPPL-30 Labeling-Container/Carton Labels, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Origs030,021555Orig1s017ltr.pdf

12/27/2012 SUPPL-29 Manufacturing (CMC)

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s029ltr.pdf

08/16/2012 SUPPL-28 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf

08/16/2012 SUPPL-27 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020832Orig1s027,s028,021555Orig1s016ltr.pdf

07/20/2010 SUPPL-26 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s026ltr.pdf

03/03/2010 SUPPL-25 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020832s025ltr.pdf

10/23/2008 SUPPL-22 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s022ltr.pdf

05/09/2007 SUPPL-18 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020832s018ltr.pdf

10/11/2006 SUPPL-16 Labeling

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s016LTR.pdf

11/21/2006 SUPPL-15 Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s015lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s015ltr.pdf

06/03/2008 SUPPL-14 Labeling-Package Insert, Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020832s014ltr.pdf

10/10/2006 SUPPL-13 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s013LTR.pdf

12/08/2006 SUPPL-12 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s012ltr.pdf

12/27/2005 SUPPL-11 Manufacturing (CMC)-Control

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s011,021555s005rev2.pdf

04/03/2006 SUPPL-10 Manufacturing (CMC)-Packaging

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020832s010ltr.pdf

05/03/2005 SUPPL-8 Manufacturing (CMC)-Formulation

Label (PDF)

Letter (PDF)

Review (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020832s008ltr.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020832_S008_CHLORAPREP_WITH_TINT.pdf

07/07/2004 SUPPL-7 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr007ltr.pdf

06/10/2004 SUPPL-6 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20832slr006ltr.pdf

08/20/2003 SUPPL-4 Manufacturing (CMC)-Packaging

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20832scp004_chloraprep_lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20832scp004ltr.pdf

04/26/2002 SUPPL-2 Manufacturing (CMC)-Control

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20832s2lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20832s002.pdf

11/27/2001 SUPPL-1 Manufacturing (CMC)-Control

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/03/2019 SUPPL-36

Manufacturing (CMC)-Manufacturing Process

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020832Orig1s036_REPLACEMENT_lbl.pdf
09/12/2017 SUPPL-42

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020832Orig1s042lbl.pdf
06/30/2014 SUPPL-34

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf
10/10/2013 SUPPL-31

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf
08/16/2012 SUPPL-30

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf
08/16/2012 SUPPL-30

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf
08/16/2012 SUPPL-28

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf
08/16/2012 SUPPL-27

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf
05/09/2007 SUPPL-18

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020832s018lbl.pdf
11/21/2006 SUPPL-15

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s015lbl.pdf
10/11/2006 SUPPL-16

Labeling

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020832s016lbl.pdf
05/03/2005 SUPPL-8

Manufacturing (CMC)-Formulation

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020832s008lbl.pdf
08/20/2003 SUPPL-4

Manufacturing (CMC)-Packaging

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20832scp004_chloraprep_lbl.pdf
04/26/2002 SUPPL-2

Manufacturing (CMC)-Control

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20832s2lbl.pdf

CHLORAPREP ONE-STEP

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

SPONGE;TOPICAL; 2%;70% (3ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

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

SPONGE;TOPICAL; 2%;70% (26ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

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

SPONGE;TOPICAL; 2%;70% (1ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

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

SPONGE;TOPICAL; 2%;70% (10.5ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

CHLORAPREP ONE-STEP FREPP

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

SPONGE;TOPICAL; 2%;70% (1.5ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP FREPP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1.5ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

CHLORAPREP WITH TINT

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

SPONGE;TOPICAL; 2%;70% (3ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (3ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

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

SPONGE;TOPICAL; 2%;70% (26ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (26ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO

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

SPONGE;TOPICAL; 2%;70% (10.5ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
CHLORAPREP WITH TINT CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (10.5ML) SPONGE;TOPICAL Over-the-counter Yes 020832 BECTON DICKINSON CO
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