Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 087509
Company: INTL MEDICATION SYS
Company: INTL MEDICATION SYS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| MEPIVACAINE HYDROCHLORIDE | MEPIVACAINE HYDROCHLORIDE | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1982 | 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-10 | Manufacturing (CMC) |
Label is not available on this site. |
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| 06/28/1994 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
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| 01/14/1998 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
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| 10/29/1993 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/08/1993 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
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| 05/07/1992 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 12/13/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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| 08/02/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/02/1990 | SUPPL-1 | Labeling |
Label is not available on this site. |