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 RHODES PHARMS
Abbreviated New Drug Application (ANDA): 089673
Company: RHODES PHARMS
| 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 |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Discontinued |
None |
No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 02/10/1988 | 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 |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/04/2019 | SUPPL-27 | REMS – MODIFIED – D-N-A |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/26/2017 | SUPPL-23 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/02/2013 | SUPPL-21 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/28/2011 | SUPPL-19 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/12/2007 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-9 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 05/16/2000 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 12/05/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/24/1997 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/29/1996 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/22/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/1994 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/28/1993 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/11/1992 | SUPPL-1 | Labeling |
Label is not available on this site. |
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