Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 089517
Company: DENTSPLY PHARM
Company: DENTSPLY PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLOCAINE W/ LEVONORDEFRIN | LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE | 0.05MG/ML;2% | INJECTABLE;INJECTION | Discontinued | 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 |
|---|---|---|---|---|---|---|---|
| 04/14/1988 | 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 |
|---|---|---|---|---|---|
| 01/15/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/13/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/19/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/18/1992 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |