Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 10MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 15MG BASE/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER | MILRINONE LACTATE | EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
---|---|---|---|---|---|---|---|
08/09/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
10/30/2007 | SUPPL-21 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s022, 020343s021ltr.pdf |
05/01/2007 | SUPPL-20 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019436s021_020343s020ltr.pdf |
04/09/2003 | SUPPL-14 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19436slr019,20343slr014ltr.pdf |
09/16/2002 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/18/2001 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
11/29/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
05/10/2000 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
07/06/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
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10/08/1998 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/25/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/15/1996 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/24/1996 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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08/13/1996 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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11/04/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |