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 HOFFMANN LA ROCHE
New Drug Application (NDA): 021455
Company: HOFFMANN LA ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BONIVA | IBANDRONATE SODIUM | EQ 2.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | TABLET;ORAL | Discontinued |
None |
Yes | No |
| BONIVA | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription |
AB |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 05/16/2003 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/07/2016 | SUPPL-21 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021455Orig1s021ltr.pdf |
||
| 04/08/2015 | SUPPL-20 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s020ltr.pdf |
||
| 03/18/2015 | SUPPL-19 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021455Orig1s019ltr.pdf |
||
| 12/17/2014 | SUPPL-18 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021455Orig1s018ltr.pdf |
||
| 06/18/2014 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/05/2013 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/19/2013 | SUPPL-15 | Labeling-Medication Guide |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf |
||
| 04/19/2013 | SUPPL-14 | Labeling-Medication Guide, Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021455Orig1s014,s015ltr.pdf |
||
| 07/01/2011 | SUPPL-13 | REMS-Modified |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s013ltr.pdf |
|
| 01/25/2011 | SUPPL-11 | REMS-Proposal |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021455s011ltr.pdf |
||
| 01/08/2010 | SUPPL-9 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021455s009ltr.pdf |
||
| 11/28/2008 | SUPPL-7 | Efficacy-New Indication |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021455s007ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021455Orig1s007.pdf |
|
| 02/13/2007 | SUPPL-5 | Labeling |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021455s005ltr.pdf |
||
| 06/14/2006 | SUPPL-3 | Labeling |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021455s003LTR.pdf |
|
| 03/24/2005 | SUPPL-1 | Efficacy-New Dosing Regimen |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21455s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001ppi.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 12/07/2016 | SUPPL-21 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021455s021lbl.pdf | |
| 04/08/2015 | SUPPL-20 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s020lbl.pdf | |
| 03/18/2015 | SUPPL-19 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021455s019lbl.pdf | |
| 12/17/2014 | SUPPL-18 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021455s18lbl.pdf | |
| 04/19/2013 | SUPPL-15 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf | |
| 04/19/2013 | SUPPL-14 |
Labeling-Medication Guide |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf | |
| 04/19/2013 | SUPPL-14 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021455s014s015lbl.pdf | |
| 01/25/2011 | SUPPL-11 |
REMS-Proposal |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021455s011lbl.pdf | |
| 01/08/2010 | SUPPL-9 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021455s009lbl.pdf | |
| 02/13/2007 | SUPPL-5 |
Labeling |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021455s005lbl.pdf | |
| 03/24/2005 | SUPPL-1 |
Efficacy-New Dosing Regimen |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021455s001lbl.pdf | |
| 05/16/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21455_boniva_lbl.pdf |
BONIVA
TABLET;ORAL; EQ 150MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BONIVA | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021455 | HOFFMANN LA ROCHE |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078948 | APOTEX INC |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 204502 | AUROBINDO PHARMA LTD |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078997 | DR REDDYS LABS LTD |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 206887 | MACLEODS PHARMS LTD |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 078998 | ORBION PHARMS |
| IBANDRONATE SODIUM | IBANDRONATE SODIUM | EQ 150MG BASE | TABLET;ORAL | Prescription | No | AB | 079003 | WATSON LABS TEVA |
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