CHLORAPREP ONE-STEP SEPP 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
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CHLORAPREP ONE-STEP SEPP از شرکت BECTON DICKINSON CO

New Drug Application (NDA): 021555

Company: BECTON DICKINSON CO

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHLORAPREP ONE-STEP SEPP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (0.67ML) SWAB;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP SINGLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1.75ML) SWAB;TOPICAL Over-the-counter

None

Yes Yes
CHLORAPREP TRIPLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (5.25ML) 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
10/07/2002 ORIG-1 Approval

Type 3 – New Dosage Form

STANDARD

Label (PDF)

Letter (PDF)

Review

https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21555ltr.pdf
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-555_Chloraprep.cfm

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/12/2017 SUPPL-24 Labeling-Container/Carton Labels, Labeling-Package Insert

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/21555Orig1s024ltr.pdf

12/22/2017 SUPPL-20 Manufacturing (CMC)-Control

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf

06/30/2014 SUPPL-19 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

10/10/2013 SUPPL-18 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-17 Labeling-Package Insert, Labeling-Container/Carton Labels

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

08/16/2012 SUPPL-16 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-15 Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021555s015ltr.pdf

03/02/2010 SUPPL-14 Labeling-Container/Carton Labels

Label is not available on this site.

08/09/2007 SUPPL-9 Labeling-Package Insert, Labeling-Container/Carton Labels

Label (PDF)

Letter (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021555s009ltr.pdf

12/20/2006 SUPPL-7 Labeling

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021555s007ltr.pdf

12/27/2005 SUPPL-5 Labeling-Container/Carton Labels, Labeling-Package Insert

Letter (PDF)

Label is not available on this site.

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

06/10/2009 SUPPL-3 Labeling-Package Insert, Labeling-Container/Carton Labels

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021555s003ltr.pdf

05/10/2005 SUPPL-1 Manufacturing (CMC)-Packaging

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021555s001ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
12/22/2017 SUPPL-20

Manufacturing (CMC)-Control

Label (PDF)

This supplement type does not usually require new labeling.

https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf
09/12/2017 SUPPL-24

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf
09/12/2017 SUPPL-24

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/21555Orig1s024lbl.pdf
06/30/2014 SUPPL-19

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020832Orig1s034, 021555Orig1s019lbl.pdf
10/10/2013 SUPPL-18

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020832Orig1s031, 021555Orig1s018lbl.pdf
08/16/2012 SUPPL-17

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.pdf
08/16/2012 SUPPL-17

Labeling-Container/Carton Labels

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

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Orig1s027, 020832Orig1s028, 021555Orig1s016lbl.pdf
08/09/2007 SUPPL-9

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf
08/09/2007 SUPPL-9

Labeling-Container/Carton Labels

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf
10/07/2002 ORIG-1 Approval

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf

CHLORAPREP ONE-STEP SEPP

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

SWAB;TOPICAL; 2%;70% (0.67ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP ONE-STEP SEPP CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (0.67ML) SWAB;TOPICAL Over-the-counter Yes 021555 BECTON DICKINSON CO

CHLORAPREP SINGLE 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; 2%;70% (1.75ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP SINGLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (1.75ML) SWAB;TOPICAL Over-the-counter Yes 021555 BECTON DICKINSON CO

CHLORAPREP TRIPLE 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; 2%;70% (5.25ML)
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD Application No. Company
CHLORAPREP TRIPLE SWABSTICK CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL 2%;70% (5.25ML) SWAB;TOPICAL Over-the-counter Yes 021555 BECTON DICKINSON CO
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