اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CALCIMAR از شرکت SANOFI AVENTIS US
New Drug Application (NDA): 017769
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| CALCIMAR | CALCITONIN SALMON | 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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. |
||
| 07/06/1993 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 09/24/1993 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/12/1993 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/06/1992 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 06/01/1992 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 04/08/1991 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 04/04/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/21/1990 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/06/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/22/1988 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 05/10/1984 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/07/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/04/1979 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/06/1979 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/10/1979 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/26/1979 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 08/14/1978 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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