Drugs@FDA: FDA-Approved Drugs
Company: SUN PHARM INDUSTRIES
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ASPIRIN | ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE | 325MG;4.5MG;0.38MG | 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 |
|---|---|---|---|---|---|---|---|
| 05/26/1982 | 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 |
|---|---|---|---|---|---|
| 03/07/2025 | SUPPL-34 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/21/2024 | SUPPL-33 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-32 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 05/04/2021 | SUPPL-31 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/09/2019 | SUPPL-29 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/20/2018 | SUPPL-28 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-27 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 03/07/2017 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-25 | Labeling-Container/Carton Labels, Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/01/1998 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/23/1994 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/03/1992 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/07/1991 | SUPPL-16 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/09/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 01/30/1990 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
| 07/14/1989 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/15/1989 | SUPPL-12 | Labeling |
Label is not available on this site. |
||
| 03/31/1988 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/01/1987 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1986 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1986 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1986 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/04/1986 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |