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
CLONAZEPAM از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 075150
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLONAZEPAM | CLONAZEPAM | 0.5MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CLONAZEPAM | CLONAZEPAM | 1MG | TABLET;ORAL | Discontinued |
None |
No | No |
| CLONAZEPAM | CLONAZEPAM | 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 |
|---|---|---|---|---|---|---|---|
| 10/05/1998 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75150LTR.PDF |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2012 | SUPPL-15 | REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
| 04/08/2011 | SUPPL-13 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide, REMS-Proposal |
Label is not available on this site. |
||
| 10/15/2009 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 11/24/2003 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 02/28/2001 | SUPPL-1 | Labeling |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
نظرات کاربران