Drugs@FDA: FDA-Approved Drugs
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. |
||
04/19/1995 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/07/2007 | SUPPL-17 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
12/31/1990 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/05/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
12/15/1989 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
08/10/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/03/1988 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
01/07/1988 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
09/24/1987 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
12/15/1989 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
01/15/1987 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
09/24/1987 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
07/28/1987 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
10/18/1985 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
05/13/1985 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
12/02/1985 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
09/20/1984 | SUPPL-1 | Labeling |
Label is not available on this site. |