Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040608
Company: MIKART
Company: MIKART
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;2.5MG | TABLET;ORAL | Prescription | None | No | Yes |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;5MG | TABLET;ORAL | Prescription | None | No | Yes |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;7.5MG | TABLET;ORAL | Prescription | None | No | Yes |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 300MG;10MG | TABLET;ORAL | Prescription | None | No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/2005 | 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 |
|---|---|---|---|---|---|
| 03/12/2024 | SUPPL-21 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-20 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 03/04/2021 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 10/08/2019 | SUPPL-16 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 09/21/2018 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-13 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
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| 08/24/2018 | SUPPL-12 | Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-11 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 12/16/2016 | SUPPL-10 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/01/2011 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/25/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |