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 UPSHER SMITH LABS
Abbreviated New Drug Application (ANDA): 075871
Company: UPSHER SMITH LABS
| 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 40MG 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 |
|---|---|---|---|---|---|---|---|
| 04/22/2009 | 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 |
|---|---|---|---|---|---|
| 02/25/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 01/20/2015 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
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