Drugs@FDA: FDA-Approved Drugs
Company: SANOFI AVENTIS US
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIMAR | CALCITONIN SALMON | 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | INJECTABLE;INJECTION | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 04/17/1978 | 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 |
|---|---|---|---|---|---|
| 05/16/1996 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/06/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 09/24/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
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| 07/12/1993 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 05/06/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
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| 06/01/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
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| 04/08/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
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| 04/04/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
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| 03/21/1990 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 07/06/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
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| 03/22/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
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| 08/08/1986 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
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| 05/10/1984 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
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| 12/07/2007 | SUPPL-10 | 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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| 05/04/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 04/06/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 01/10/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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| 11/26/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
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| 08/14/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |