Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 088653
Company: DENTSPLY PHARM
Company: DENTSPLY PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| POLOCAINE | MEPIVACAINE HYDROCHLORIDE | 3% | 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 |
|---|---|---|---|---|---|---|---|
| 08/21/1984 | 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-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2001 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 09/29/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/13/1993 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 09/18/1992 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1989 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 06/07/1985 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |