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 IN DEXTROSE 5% IN PLASTIC CONTAINER از شرکت B BRAUN
New Drug Application (NDA): 019121
Company: B BRAUN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 100MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 200MG/100ML | INJECTABLE;INJECTION | Discontinued |
None |
No | No |
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 400MG/100ML | 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 |
|---|---|---|---|---|---|---|---|
| 04/29/1986 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/06/1993 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 07/13/1990 | SUPPL-2 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
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