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
CO-GESIC از شرکت UCB INC
Abbreviated New Drug Application (ANDA): 087757
Company: UCB INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CO-GESIC | ACETAMINOPHEN; HYDROCODONE BITARTRATE | 500MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/03/1982 | 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 |
|---|---|---|---|---|---|
| 01/26/2008 | SUPPL-30 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/29/1999 | SUPPL-27 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/09/1998 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/30/1996 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/20/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 12/06/1995 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/30/1991 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 03/29/1990 | SUPPL-16 | Labeling |
Label is not available on this site. |
||
| 02/07/1989 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 04/20/1989 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/29/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/29/1986 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/1985 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1984 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/24/1984 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
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