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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022272
Company: KNOA PHARMA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
OXYCONTIN OXYCODONE HYDROCHLORIDE 10MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 15MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
OXYCONTIN OXYCODONE HYDROCHLORIDE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
OXYCONTIN OXYCODONE HYDROCHLORIDE 80MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
12/22/2025 SUPPL-52 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022272s052lbl.pdf
12/15/2023 SUPPL-48 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/022272s048lbl.pdf
10/28/2021 SUPPL-47 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s047lbl.pdf
03/04/2021 SUPPL-46 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022272s046lbl.pdf
10/07/2019 SUPPL-43 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022272s043lbl.pdf
09/26/2018 SUPPL-39 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s039lbl.pdf
09/18/2018 SUPPL-41 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf
09/18/2018 SUPPL-40 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022272s040s041lbl.pdf
12/16/2016 SUPPL-34 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022272s034lbl.pdf
08/13/2015 SUPPL-27 Efficacy-Pediatric Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022272s027lbl.pdf
10/22/2014 SUPPL-23 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272Orig1s023lbl.pdf
04/16/2014 SUPPL-22 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022272s022lbl.pdf
04/16/2013 SUPPL-14 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272Orig1s014lbl.pdf
01/11/2013 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022272s016lbl.pdf
07/09/2012 SUPPL-11 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s011lbl.pdf
07/09/2012 SUPPL-10 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf
07/09/2012 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022272s010lbl.pdf
10/05/2011 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022272s009lbl.pdf
11/15/2010 SUPPL-6 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s006lbl.pdf
06/29/2010 SUPPL-5 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272s005lbl.pdf
04/05/2010 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022272lbl.pdf
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