Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084697
Company: SEPTODONT
Company: SEPTODONT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ISOCAINE HYDROCHLORIDE 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 |
|---|---|---|---|---|---|---|---|
| 02/06/1976 | 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 |
|---|---|---|---|---|---|
| 08/02/1999 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
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| 04/19/1993 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/13/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/26/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/13/1994 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/07/1992 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 09/12/1984 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/13/1983 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/11/1984 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/11/1982 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1982 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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| 07/09/1982 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |