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 DURAMED PHARMS BARR
Abbreviated New Drug Application (ANDA): 040223
Company: DURAMED PHARMS BARR
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|
| 11/18/1997 | 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 |
|---|---|---|---|---|---|
| 10/21/2013 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/21/2013 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/14/2008 | SUPPL-23 | Labeling |
Label is not available on this site. |
||
| 10/25/2007 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-13 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 12/09/2002 | SUPPL-12 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-10 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/09/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 06/05/2000 | SUPPL-2 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/20/1999 | SUPPL-1 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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