Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 040105
Company: PH HEALTH
Company: PH HEALTH
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;5MG | 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 |
|---|---|---|---|---|---|---|---|
| 07/30/1996 | ORIG-1 | Approval |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/anda/96/040105ap.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/31/2024 | SUPPL-39 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
| 03/12/2024 | SUPPL-38 | Labeling-Package Insert, Labeling |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-37 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/18/2023 | SUPPL-36 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-34 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-32 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-31 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-28 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-27 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 12/16/2016 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/18/2013 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/21/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/29/2007 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/17/1997 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |