Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 084850
Company: BELMORA LLC
Company: BELMORA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPIVACAINE 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 |
|---|---|---|---|---|---|---|---|
| 01/22/1976 | 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 |
|---|---|---|---|---|---|
| 08/10/1994 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 12/22/1993 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 08/25/1993 | SUPPL-29 | Labeling |
Label is not available on this site. |
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| 03/24/1993 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 10/31/1989 | SUPPL-27 | Labeling |
Label is not available on this site. |
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| 08/04/1988 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/04/1988 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/03/1987 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/24/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/02/1982 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |