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
BONIVA از شرکت ROCHE
New Drug Application (NDA): 021858
Company: ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BONIVA | IBANDRONATE SODIUM | EQ 3MG BASE/3ML | INJECTABLE;INTRAVENOUS | 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 |
|---|---|---|---|---|---|---|---|
| 01/06/2006 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2016 | SUPPL-22 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021858Orig1s022ltr.pdf |
||
| 07/22/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/08/2015 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s020ltr.pdf |
||
| 03/18/2015 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021858Orig1s019ltr.pdf |
||
| 05/04/2015 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/08/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/2014 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/18/2014 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-14 | Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf |
||
| 04/19/2013 | SUPPL-13 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf |
||
| 07/01/2011 | SUPPL-12 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s012ltr.pdf |
|
| 08/10/2011 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s010ltr.pdf |
|
| 01/25/2011 | SUPPL-9 | REMS-Proposal |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021858s009ltr.pdf |
||
| 04/19/2013 | SUPPL-8 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021858Orig1s008,s013,s014ltr.pdf |
||
| 02/12/2007 | SUPPL-4 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021858s004ltr.pdf |
|
| 08/07/2006 | SUPPL-1 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021858s001LTR.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/07/2016 | SUPPL-22 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021858s022lbl.pdf | |
| 04/08/2015 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s020lbl.pdf | |
| 03/18/2015 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021858s019lbl.pdf | |
| 04/19/2013 | SUPPL-14 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf | |
| 04/19/2013 | SUPPL-13 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf | |
| 04/19/2013 | SUPPL-8 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021858s008s013s014lbl.pdf | |
| 01/25/2011 | SUPPL-9 |
REMS-Proposal |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021858s009lbl.pdf | |
| 08/07/2006 | SUPPL-1 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s001lbl.pdf | |
| 01/06/2006 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021858s000lbl.pdf |
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