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
ACETAMINOPHEN AND CODEINE PHOSPHATE از شرکت MIKART
Abbreviated New Drug Application (ANDA): 089244
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | 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 |
|---|---|---|---|---|---|---|---|
| 02/25/1986 | 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-19 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/31/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-17 | Labeling |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/07/1997 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/30/1995 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 07/20/1993 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/21/1988 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/20/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/18/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/16/1991 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 06/04/1987 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/06/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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