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
BUTAPAP از شرکت MIKART
Abbreviated New Drug Application (ANDA): 089988
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BUTAPAP | ACETAMINOPHEN; BUTALBITAL | 650MG;50MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/26/1992 | 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 |
|---|---|---|---|---|---|
| 08/13/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/28/2001 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1998 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/24/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 02/08/1995 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/08/1994 | SUPPL-1 | Labeling |
Label is not available on this site. |
نظرات کاربران