Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 201194
Company: VISTAPHARM LLC
Company: VISTAPHARM LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXYCODONE HYDROCHLORIDE | OXYCODONE HYDROCHLORIDE | 5MG/5ML | SOLUTION;ORAL | Discontinued | None | Yes | 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 |
---|---|---|---|---|---|---|---|
01/12/2012 | ORIG-1 | Approval | Type 7 - Drug Already Marketed without Approved NDA | STANDARD |
Label (PDF)
Letter (PDF) Review Summary Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/201194s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/201194Orig1s000SumR.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
04/19/2024 | SUPPL-19 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/201194Orig1s019ltr.pdf | |
12/15/2023 | SUPPL-17 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201194Orig1s017ltr.pdf | |
03/04/2021 | SUPPL-10 | Labeling-Package Insert, Labeling-Medication Guide |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201194Orig1s010ltr.pdf | |
07/21/2021 | SUPPL-9 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201194Orig1s009ltr.pdf | |
10/07/2019 | SUPPL-8 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201194Orig1s008ltr.pdf | |
09/18/2018 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf | |
09/18/2018 | SUPPL-3 | REMS - PROPOSAL - D-N-A |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201194Orig1003s004ltr.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201194Orig1s002ltr.pdf | |
06/02/2014 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
04/19/2024 | SUPPL-19 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf | |
04/19/2024 | SUPPL-19 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/201194s019lbl.pdf | |
12/15/2023 | SUPPL-17 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf | |
12/15/2023 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201194s017lbl.pdf | |
07/21/2021 | SUPPL-9 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s009lbl.pdf | |
03/04/2021 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf | |
03/04/2021 | SUPPL-10 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201194s010lbl.pdf | |
10/07/2019 | SUPPL-8 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf | |
10/07/2019 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201194s008lbl.pdf | |
09/18/2018 | SUPPL-4 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf | |
09/18/2018 | SUPPL-4 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf | |
09/18/2018 | SUPPL-3 | REMS - PROPOSAL - D-N-A | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201194s003s004lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf | |
12/16/2016 | SUPPL-2 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201194s002lbl.pdf | |
01/12/2012 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/201194s000lbl.pdf |