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 HOSPIRA INC
New Drug Application (NDA): 019008
Company: HOSPIRA INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER | BRETYLIUM TOSYLATE | 800MG/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 |
|---|---|---|---|---|---|---|---|
| 04/16/1986 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
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 |
|---|---|---|---|---|---|
| 06/29/2001 | SUPPL-21 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
||
| 11/05/1998 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/16/1999 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 06/12/1997 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/18/1997 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/02/1996 | SUPPL-16 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/03/1995 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/26/1996 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/04/1994 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/18/1991 | SUPPL-11 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 12/31/1991 | SUPPL-10 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 03/20/1990 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/23/1990 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/22/1988 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/16/1987 | SUPPL-6 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/26/1987 | SUPPL-5 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/29/1986 | SUPPL-4 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 03/13/1987 | SUPPL-3 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/08/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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