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 WATSON LABS
Abbreviated New Drug Application (ANDA): 089998
Company: WATSON LABS
| 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 |
|---|---|---|---|---|---|---|---|
| 12/28/1994 | 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-24 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-23 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-22 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-21 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-19 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-18 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/03/2015 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2001 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/17/2000 | SUPPL-5 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 08/21/1998 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/28/1996 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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