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
ALENDRONATE SODIUM از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 076584
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 5MG BASE | TABLET;ORAL | Discontinued |
None |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 10MG BASE | TABLET;ORAL | Discontinued |
None |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 35MG BASE | TABLET;ORAL | Discontinued |
None |
No | No |
| ALENDRONATE SODIUM | ALENDRONATE SODIUM | EQ 70MG BASE | TABLET;ORAL | Discontinued |
None |
No | 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 |
|---|---|---|---|---|---|---|---|
| 08/04/2008 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/08/2016 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/16/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/17/2012 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2013 | SUPPL-9 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/02/2011 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert, REMS-Proposal |
Label is not available on this site. |
||
| 05/04/2011 | SUPPL-5 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 11/20/2009 | SUPPL-3 | Labeling-Container/Carton Labels |
Label is not available on this site. |
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