Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021555
Company: BECTON DICKINSON CO
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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/30/2023 | SUPPL-28 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021555Orig1s028lbl.pdf | |
| 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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020832Origs030, 021555Orig1s017lbl.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-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-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021555s009lbl.pdf | |
| 08/09/2007 | SUPPL-9 | Labeling-Package Insert | 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 |