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
BRETYLIUM TOSYLATE از شرکت LUITPOLD
Abbreviated New Drug Application (ANDA): 070891
Company: LUITPOLD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE | BRETYLIUM TOSYLATE | 50MG/ML | INJECTABLE;INJECTION | 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 |
|---|---|---|---|---|---|---|---|
| 07/26/1988 | 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 |
|---|---|---|---|---|---|
| 04/23/2001 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/23/2001 | SUPPL-9 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 04/12/2000 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 12/17/1998 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/25/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/29/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/08/1994 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/14/1994 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/12/1991 | SUPPL-1 | Labeling |
Label is not available on this site. |
نظرات کاربران