Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208795
Company: HIKMA
Company: HIKMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 100MG/5ML | SOLUTION;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 |
|---|---|---|---|---|---|---|---|
| 08/07/2017 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 04/06/2020 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 04/06/2020 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-1 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |