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 HIKMA PHARMS
Abbreviated New Drug Application (ANDA): 070546
Company: HIKMA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 05/14/1986 | 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 |
|---|---|---|---|---|---|
| 06/22/1994 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 04/03/1990 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/09/1990 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/24/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/03/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/04/1986 | SUPPL-1 | Labeling |
Label is not available on this site. |
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