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
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE از شرکت WATSON LABS
Abbreviated New Drug Application (ANDA): 089536
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ACETAMINOPHEN AND CAFFEINE | ACETAMINOPHEN; BUTALBITAL; CAFFEINE | 325MG;50MG;40MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 02/16/1988 | 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 |
|---|---|---|---|---|---|
| 11/03/2015 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/29/2003 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-22 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-21 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/24/2002 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-17 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/24/2001 | SUPPL-16 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/02/2001 | SUPPL-15 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-14 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/18/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 08/08/2000 | SUPPL-10 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 02/04/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1994 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 05/08/1992 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 08/16/1991 | SUPPL-6 | Labeling |
Label is not available on this site. |
||
| 06/02/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
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