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
ALPRAZOLAM از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 074215
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALPRAZOLAM | ALPRAZOLAM | 0.25MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALPRAZOLAM | ALPRAZOLAM | 0.5MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALPRAZOLAM | ALPRAZOLAM | 1MG | TABLET;ORAL | Discontinued |
None |
No | No |
| ALPRAZOLAM | ALPRAZOLAM | 2MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/27/1994 | 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 |
|---|---|---|---|---|---|
| 12/31/2019 | SUPPL-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/27/2011 | SUPPL-20 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/01/2012 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2008 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/03/2002 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 10/18/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 05/06/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/03/1998 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/1998 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/07/1997 | SUPPL-1 | Labeling |
Label is not available on this site. |
حتما بخوانید : ALPRAZOLAM از شرکت HIKMA
منبع : www.accessdata.fda.gov
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