Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 202142
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/5ML;10MG/5ML | SOLUTION;ORAL | Prescription | 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 |
|---|---|---|---|---|---|---|---|
| 11/27/2018 | ORIG-1 | Approval | Not Applicable |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202142Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/15/2024 | SUPPL-9 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 01/09/2024 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/29/2020 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |