Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077250
Company: SEPTODONT
Company: SEPTODONT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VIVACAINE | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE | 0.5%;0.0091MG/ML | INJECTABLE;INJECTION | Prescription | None | No | 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 |
|---|---|---|---|---|---|---|---|
| 09/27/2006 | 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 |
|---|---|---|---|---|---|
| 08/27/2015 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2013 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/29/2007 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 01/30/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |