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, ASPIRIN AND CAFFEINE از شرکت ACTAVIS ELIZABETH
Abbreviated New Drug Application (ANDA): 086710
Company: ACTAVIS ELIZABETH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTALBITAL, ASPIRIN AND CAFFEINE | ASPIRIN; 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 |
|---|---|---|---|---|---|---|---|
| 07/25/1979 | 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 |
|---|---|---|---|---|---|
| 11/02/2001 | SUPPL-46 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1999 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 11/23/1998 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-43 | Labeling |
Label is not available on this site. |
||
| 05/09/1997 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/18/1996 | SUPPL-41 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/25/1991 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 10/04/1989 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/04/1989 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 11/05/1990 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1990 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1990 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1985 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1985 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1985 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/15/1985 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1983 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/06/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/25/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
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