Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 074522
Company: PHARM ASSOC
Company: PHARM ASSOC
| 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 |
|---|---|---|---|---|---|---|---|
| 12/15/1995 | 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 |
|---|---|---|---|---|---|
| 10/18/2021 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 08/30/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/19/1999 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 02/24/1998 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/15/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/02/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/31/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1996 | SUPPL-1 | Manufacturing (CMC) |
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 |