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 FOSUN PHARMA
Abbreviated New Drug Application (ANDA): 086398
Company: FOSUN PHARMA
| 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1980 | 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 |
|---|---|---|---|---|---|
| 01/13/2000 | SUPPL-46 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 10/28/1996 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1992 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 11/09/1990 | SUPPL-43 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/01/1990 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 01/15/1988 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/23/1987 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1984 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/19/1984 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/06/1984 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1984 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/27/1984 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/06/1984 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1983 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/14/1983 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1982 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1982 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/17/1982 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
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