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 NOSTRUM LABS INC
Abbreviated New Drug Application (ANDA): 088627
Company: NOSTRUM LABS INC
| 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 | Prescription |
AA |
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 |
|---|---|---|---|---|---|---|---|
| 03/06/1985 | 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-63 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-62 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-60 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-58 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-57 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-53 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/10/2013 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/22/2011 | SUPPL-48 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2008 | SUPPL-45 | Labeling |
Label is not available on this site. |
||
| 01/07/2008 | SUPPL-44 | Labeling |
Label is not available on this site. |
||
| 07/07/2000 | SUPPL-40 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/03/1999 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-38 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/09/1998 | SUPPL-36 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/06/1997 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/04/1997 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/27/1996 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/16/1996 | SUPPL-32 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/20/1995 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/03/1995 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/27/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 03/02/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-24 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/26/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/22/1993 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1993 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-15 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/25/1993 | SUPPL-14 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1993 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/05/1994 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/30/1992 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/11/1990 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 04/08/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/10/1986 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;15MG
TE Code = AA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 211610 | EYWA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 088627 | NOSTRUM LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;15MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
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