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 HIKMA PHARMS
Abbreviated New Drug Application (ANDA): 089718
Company: HIKMA PHARMS
| 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 |
|---|---|---|---|---|---|---|---|
| 06/12/1995 | 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 |
|---|---|---|---|---|---|
| 06/01/2016 | SUPPL-17 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/03/2003 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 08/23/2001 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2001 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/01/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/25/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/27/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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