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
BUCET از شرکت MALLINCKRODT
Abbreviated New Drug Application (ANDA): 088991
Company: MALLINCKRODT
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUCET | ACETAMINOPHEN; BUTALBITAL | 650MG;50MG | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 06/28/1985 | 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 |
|---|---|---|---|---|---|
| 08/30/1996 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/29/1994 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/12/1994 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 04/12/1994 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 03/20/1992 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/05/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 08/18/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1989 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/08/1992 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/27/1992 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
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