Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077789
Company: XTTRIUM
Company: XTTRIUM
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CHLORHEXIDINE GLUCONATE | CHLORHEXIDINE GLUCONATE | 0.12% | SOLUTION;DENTAL | Prescription | AT | 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 |
---|---|---|---|---|---|---|---|
06/18/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
08/08/2023 | SUPPL-11 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
07/28/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
CHLORHEXIDINE GLUCONATE
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 |