Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 083559
Company: BELMORA LLC
Company: BELMORA LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
MEPIVACAINE HYDROCHLORIDE | 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 |
---|---|---|---|---|---|---|---|
12/04/1973 | 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-23 | Labeling |
Label is not available on this site. |
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03/04/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
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10/25/1990 | SUPPL-21 | Labeling |
Label is not available on this site. |
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11/29/1989 | SUPPL-20 | Labeling |
Label is not available on this site. |
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11/03/1988 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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11/04/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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01/31/1985 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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01/31/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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10/20/1983 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |