Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021524
Company: PROF DSPLS
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 |
|---|---|---|---|---|---|
| 09/20/2021 | SUPPL-24 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021524Orig1s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021524Orig1s024ltr.pdf | |
| 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 | Efficacy-Labeling Change With Clinical Data, Labeling-Container/Carton Labels |
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-Container/Carton Labels, Labeling-Package Insert |
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 |
|---|---|---|---|---|---|
| 09/20/2021 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021524Orig1s024lbl.pdf | |
| 09/20/2021 | SUPPL-24 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021524Orig1s024lbl.pdf | |
| 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 |