Drugs@FDA: FDA-Approved Drugs
Company: XTTRIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
EXIDINE | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
12/24/1984 | 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 |
---|---|---|---|---|---|
09/29/2022 | SUPPL-45 | Manufacturing (CMC)-Packaging |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019125Orig1s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/019125Orig1s045ltr.pdf | |
09/14/2017 | SUPPL-44 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019125Orig1s044ltr.pdf | |
10/17/2014 | SUPPL-42 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019125Orig1s042ltr.pdf | |
11/09/2012 | SUPPL-40 | Labeling-Package Insert |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019125Orig1s040ltr.pdf |
05/16/2005 | SUPPL-34 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019125s034ltr.pdf |
10/08/1999 | SUPPL-31 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
09/08/1999 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
09/11/1998 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/06/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/19-125S028.pdf |
05/06/1996 | SUPPL-27 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
04/12/1996 | SUPPL-26 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/21/1996 | SUPPL-25 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
02/06/1996 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/06/1996 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/28/1995 | SUPPL-21 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
05/10/1995 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
05/10/1995 | SUPPL-18 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
11/06/1992 | SUPPL-17 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
03/07/1991 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/23/1990 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/14/1989 | SUPPL-10 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
08/25/1988 | SUPPL-6 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
12/27/1989 | SUPPL-4 | Efficacy-New Indication |
Label is not available on this site. |
||
09/04/1985 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
06/09/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/29/2022 | SUPPL-45 | Manufacturing (CMC)-Packaging | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/019125Orig1s045lbl.pdf | |
09/14/2017 | SUPPL-44 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019125Orig1s044lbl.pdf | |
10/17/2014 | SUPPL-42 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019125Orig1s042lbl.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; 4%
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | Application No. | Company |
---|---|---|---|---|---|---|---|
CHG SCRUB | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019258 | ECOLAB |
EXIDINE | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | No | 019125 | XTTRIUM |
HIBICLENS | CHLORHEXIDINE GLUCONATE | 4% | SOLUTION;TOPICAL | Over-the-counter | Yes | 017768 | MOLNLYCKE HLTH |