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 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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21555lbl.pdf |
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 |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021555Origs020lbl.pdf |
||
| 06/30/2014 | SUPPL-19 | Labeling-Container/Carton Labels |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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 |
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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