Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 018700
Company: SANOFI AVENTIS US
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| INOCOR | INAMRINONE LACTATE | EQ 5MG BASE/ML | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1984 | ORIG-1 | Approval | Type 1 - New Molecular Entity | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/28/2000 | SUPPL-19 | Labeling |
Label is not available on this site. |
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| 04/19/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-17 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
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| 12/31/1990 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/05/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
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| 12/15/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
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| 08/10/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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| 02/03/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 01/07/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
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| 09/24/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
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| 12/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
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| 01/15/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
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| 09/24/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
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| 07/28/1987 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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| 10/18/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
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| 05/13/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
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| 12/02/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 09/20/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |