Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 090177
Company: DR REDDYS LABS SA
Company: DR REDDYS LABS SA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;2.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | TABLET;ORAL | Discontinued | None | No | No |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | TABLET;ORAL | Discontinued | None | No | No |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 500MG;7.5MG | TABLET;ORAL | Discontinued | None | No | No |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 650MG;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/20/2008 | 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-18 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/20/2018 | SUPPL-14 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-12 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-10 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 06/24/2015 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/14/2016 | SUPPL-4 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 06/27/2011 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |