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 SUN PHARM INDS LTD
Abbreviated New Drug Application (ANDA): 085868
Company: SUN PHARM INDS LTD
| 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 | 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 |
|---|---|---|---|---|---|---|---|
| 11/06/1978 | 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 |
|---|---|---|---|---|---|
| 03/04/2021 | SUPPL-66 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-65 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-64 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-63 | REMS – PROPOSAL – D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-62 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-61 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-60 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-59 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-58 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2013 | SUPPL-57 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-56 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2008 | SUPPL-55 | Labeling |
Label is not available on this site. |
||
| 10/18/2007 | SUPPL-54 | Labeling |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-48 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-47 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-45 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-44 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-43 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-42 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-40 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-39 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/1989 | SUPPL-38 | Labeling |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-37 | Labeling |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-30 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/15/1985 | SUPPL-28 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/13/1982 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1982 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/14/1982 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;30MG
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;30MG | TABLET;ORAL | Prescription | No | AA | 040779 | AMNEAL PHARMS NY |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 211610 | EYWA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 088629 | NOSTRUM LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;30MG | TABLET;ORAL | Prescription | No | AA | 085868 | SUN PHARM INDS LTD |
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