Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 086402
Company: INTL MEDICATION
Company: INTL MEDICATION
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE | EPINEPHRINE; LIDOCAINE HYDROCHLORIDE | 0.01MG/ML;1% | 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 |
|---|---|---|---|---|---|---|---|
| 02/04/1980 | 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 |
|---|---|---|---|---|---|
| 09/19/1995 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/17/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/15/1993 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 01/14/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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| 12/17/1992 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/30/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/13/1991 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 04/21/1988 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 04/27/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 04/27/1987 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |