Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 203573
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG/5ML;5MG/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 |
|---|---|---|---|---|---|---|---|
| 12/18/2014 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/203573Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 12/05/2025 | SUPPL-16 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/31/2024 | SUPPL-15 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 04/18/2024 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-13 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-6 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-5 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |