Drugs@FDA: FDA-Approved Drugs
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;60MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/23/1980 | 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 |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-57 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-54 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-53 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/07/2019 | SUPPL-52 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-51 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-50 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-49 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2017 | SUPPL-48 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-47 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2014 | SUPPL-45 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/14/2013 | SUPPL-44 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/23/2011 | SUPPL-43 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/05/2008 | SUPPL-42 | Labeling |
Label is not available on this site. |
||
| 10/18/2007 | SUPPL-41 | Labeling |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-35 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-34 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-32 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/03/2002 | SUPPL-31 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2000 | SUPPL-30 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/05/1995 | SUPPL-29 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-27 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/09/1995 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/29/1989 | SUPPL-25 | Labeling |
Label is not available on this site. |
||
| 08/25/1988 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/06/1987 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/21/1986 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
ACETAMINOPHEN AND CODEINE PHOSPHATE
TABLET;ORAL; 300MG;60MG
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;60MG | TABLET;ORAL | Prescription | No | AA | 202800 | AUROLIFE PHARMA LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 212418 | ELITE LABS INC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 040419 | SPECGX LLC |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 089828 | STRIDES PHARMA |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 087083 | SUN PHARM INDS LTD |
| ACETAMINOPHEN AND CODEINE PHOSPHATE | ACETAMINOPHEN; CODEINE PHOSPHATE | 300MG;60MG | TABLET;ORAL | Prescription | No | AA | 211610 | WES PHARMA INC |