Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 080504
Company: BELMORA LLC
Company: BELMORA LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE | LIDOCAINE HYDROCHLORIDE | 2% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;2% | INJECTABLE;INJECTION | Discontinued | None | No | No |
| LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.02MG/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 |
|---|---|---|---|---|---|---|---|
| 02/23/1972 | 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 |
|---|---|---|---|---|---|
| 10/01/1992 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 10/11/1989 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 11/08/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/23/1988 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/23/1987 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1985 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/09/1985 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/19/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |