Drugs@FDA: FDA-Approved Drugs
Company: 3M
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PERIDEX | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
08/13/1986 | ORIG-1 | Approval | Type 3 - New Dosage Form | PRIORITY |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
01/16/2013 | SUPPL-22 | Manufacturing (CMC) |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf | |
04/09/2013 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/16/2013 | SUPPL-20 | Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019028Orig1s020ltr.pdf | |
09/28/2010 | SUPPL-15 | Manufacturing (CMC) |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019028s015ltr.pdf |
08/08/2007 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
06/07/1999 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/07/1999 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
11/21/1997 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/08/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
01/08/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
01/08/1997 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
12/04/1992 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/20/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/25/1991 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
03/31/1988 | SUPPL-1 | Labeling |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
01/16/2013 | SUPPL-22 | Manufacturing (CMC) | Label (PDF) | This supplement type does not usually require new labeling. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s022lbl.pdf |
01/16/2013 | SUPPL-20 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019028s020lbl.pdf |
PERIDEX
SOLUTION;DENTAL; 0.12%
TE Code = AT
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 075561 | BAJAJ |
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 075006 | CHARTWELL RX |
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 074291 | LYNE |
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 074522 | PHARM ASSOC |
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 077789 | XTTRIUM |
PERIDEX | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | Yes | AT | 019028 | 3M |
PERIOGARD | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | No | AT | 203212 | COLGATE-PALMOLIVE CO |