FDA Approval for OXYCODONE AND ACETAMINOPHEN issued to LANNETT CO INC
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Biotechnology: Pharmaceutical Preparations
Health Care
Abbreviated New Drug Application (ANDA): 207333
Company: LANNETT CO INC
Company: LANNETT CO INC
| 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 |
| OXYCODONE AND ACETAMINOPHEN | ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE | 325MG;10MG | 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 |
|---|---|---|---|---|---|---|---|
| 09/25/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207333Orig1s000ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/13/2024 | SUPPL-12 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/15/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 03/04/2021 | SUPPL-7 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/08/2019 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 09/21/2018 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/18/2018 | SUPPL-3 | REMS - PROPOSAL - D-N-A |
Label is not available on this site. |