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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202080
Company: ZYLA

Medication Guide

REMS

Products on NDA 202080

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXAYDO	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Discontinued	None	Yes	No
OXAYDO	OXYCODONE HYDROCHLORIDE	7.5MG	TABLET;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202080

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/17/2011	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202080s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202080_oxecta_toc.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-14	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202080s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/202080Orig1s014ltr.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202080s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/202080Orig1s013ltr.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202080s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202080Orig1s012ltr.pdf
10/07/2019	SUPPL-11	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202080Orig1s011ltr.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf
09/18/2018	SUPPL-9	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202080Orig1s009s010ltr.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf
12/16/2016	SUPPL-5	Labeling-Package Insert, Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202080Orig1s005,s006ltr.pdf
03/07/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
01/26/2015	SUPPL-3	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202080Orig1s003ltr.pdf
01/16/2014	SUPPL-2	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202080Origs002ltr.pdf
06/03/2013	SUPPL-1	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202080Orig1s001ltr.pdf

Labels for NDA 202080

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-14	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/202080s014lbl.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/202080s013lbl.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202080s012lbl.pdf
10/07/2019	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf
10/07/2019	SUPPL-11	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202080s011lbl.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf
09/18/2018	SUPPL-9	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202080s009s010lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
12/16/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202080s005s006lbl.pdf
01/26/2015	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202080Orig1s003lbl.pdf
01/16/2014	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202080s002lbl.pdf
06/03/2013	SUPPL-1	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202080s001lbl.pdf
06/17/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202080s000lbl.pdf

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