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
CHLORHEXIDINE GLUCONATE از شرکت SAGE PRODS
New Drug Application (NDA): 021669
Company: SAGE PRODS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 2% | CLOTH;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 |
|---|---|---|---|---|---|---|---|
| 04/25/2005 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021669lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 09/06/2017 | SUPPL-23 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021669Orig1s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021669Orig1s023ltr.pdf |
||
| 06/07/2016 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/16/2015 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/24/2014 | SUPPL-19 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021669Orig1s019ltr.pdf |
||
| 11/22/2013 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/2013 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/26/2012 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2012 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021669s014ltr.pdf |
|
| 02/01/2007 | SUPPL-6 |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021669_s006_chlorhexidine gluconate.pdf |
||
| 07/24/2006 | SUPPL-4 |
Label is not available on this site. |
|||
| 08/17/2006 | SUPPL-3 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s003LTR.pdf |
||
| 01/13/2006 | SUPPL-2 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021669s002ltr.pdf |
|
| 02/17/2006 | SUPPL-1 |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 09/06/2017 | SUPPL-23 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021669Orig1s023lbl.pdf | |
| 06/24/2014 | SUPPL-19 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021669Orig1s019lbl.pdf | |
| 08/17/2006 | SUPPL-3 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021669s003lbl.pdf | |
| 04/25/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021669lbl.pdf |
CHLORHEXIDINE GLUCONATE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
CLOTH;TOPICAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 2% | CLOTH;TOPICAL | Over-the-counter | Yes | 021669 | SAGE PRODS |
| READYPREP CHG | CHLORHEXIDINE GLUCONATE | 2% | CLOTH;TOPICAL | Over-the-counter | No | 207964 | MEDLINE INDUSTRIES |
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