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
CALCIJEX از شرکت ABBVIE
New Drug Application (NDA): 018874
Company: ABBVIE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CALCIJEX | CALCITRIOL | 0.001MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |
None |
Yes | No |
| CALCIJEX | CALCITRIOL | 0.002MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE;INJECTION | Discontinued |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 |
|---|---|---|---|---|---|---|---|
| 09/25/1986 | 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 |
|---|---|---|---|---|---|
| 03/09/2012 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/018874s022ltr.pdf |
||
| 07/01/2007 | SUPPL-19 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/018874s019_ltr.pdf |
|
| 11/16/2001 | SUPPL-16 | Efficacy-Labeling Change With Clinical Data |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18874s16ltr.pdf |
|
| 05/07/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/29/2001 | SUPPL-14 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 09/15/2000 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/02/1999 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 05/26/1999 | SUPPL-11 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/2000 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 12/31/1997 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/10/1997 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/22/1996 | SUPPL-7 | Efficacy-New Dosing Regimen |
Label is not available on this site. |
||
| 01/05/1996 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/31/1995 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/04/1990 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 07/25/1991 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 03/09/2012 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/018874s022lbl.pdf |
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