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 MUTUAL PHARM
Abbreviated New Drug Application (ANDA): 085794
Company: MUTUAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/20/1978 | 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 |
|---|---|---|---|---|---|
| 12/01/1998 | SUPPL-47 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/24/1996 | SUPPL-46 | Labeling |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-45 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-44 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/05/1991 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 12/22/1989 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/09/1989 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-37 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/18/1988 | SUPPL-35 | Labeling |
Label is not available on this site. |
||
| 05/24/1990 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 05/06/1988 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/17/1988 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/31/1987 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1988 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1985 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/26/1985 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1985 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1985 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1985 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/01/1985 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
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