Drugs@FDA: FDA-Approved Drugs
Company: XTTRIUM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| EXIDINE | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 12/17/1985 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/25/2019 | SUPPL-49 |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019422Orig1s049Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019422Orig1s049ltr.pdf | ||
| 09/15/2017 | SUPPL-47 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019422Orig1s047ltr.pdf |
| 04/11/2016 | SUPPL-46 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/24/2016 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/12/2012 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019422Orig1s043ltr.pdf | |
| 02/25/2009 | SUPPL-37 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s037ltr.pdf |
| 02/25/2009 | SUPPL-36 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019422s036ltr.pdf |
| 12/20/2004 | SUPPL-33 | Manufacturing (CMC)-Packaging |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/019422s033ltr.pdf |
| 12/19/2003 | SUPPL-32 | Efficacy-Labeling Change With Clinical Data |
Letter (PDF)
Review |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19422se8-032ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/019422_S032_ChlorhexidineTOC.cfm |
| 10/08/1999 | SUPPL-29 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/29/2000 | SUPPL-28 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/19/1998 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/30/1998 | SUPPL-26 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/08/1998 | SUPPL-25 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/17/1997 | SUPPL-24 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/11/1997 | SUPPL-23 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/06/1996 | SUPPL-22 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/03/1996 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/12/1996 | SUPPL-20 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/06/1996 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/06/1996 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/10/1995 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 11/06/1992 | SUPPL-15 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 07/28/1989 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/12/1988 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/28/1988 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/1988 | SUPPL-5 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/02/1988 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/27/1989 | SUPPL-1 | Efficacy-New Indication |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/25/2019 | SUPPL-49 | Manufacturing (CMC) | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019422Orig1s049Lbl.pdf | |
| 12/12/2012 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019422Orig1s043lbl.pdf |
EXIDINE
The products listed here are over-the-counter (OTC) drugs and do not receive therapeutic equivalence ratings. They may not be interchangeable.
SOLUTION;TOPICAL; 2%
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
|---|---|---|---|---|---|---|---|
| CIDA-STAT | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;TOPICAL | Over-the-counter | No | 019258 | ECOLAB |
| EXIDINE | CHLORHEXIDINE GLUCONATE | 2% | SOLUTION;TOPICAL | Over-the-counter | Yes | 019422 | XTTRIUM |