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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200534
Company: GENUS LIFESCIENCES

Medication Guide

REMS

Summary Review

Products on NDA 200534

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200534

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/20/2010	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/2010/200534s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200534s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534s000_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200534Orig1s000SumR.pdf

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/2024/200534s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200534Orig1s014ltr.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200534s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200534Orig1s013ltr.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200534Orig1s011ltr.pdf
07/21/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200534Orig1s010, 200535Orig1s017ltr.pdf
10/07/2019	SUPPL-9	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200534Orig1s009ltr.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200534Orig1s007s008ltr.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200534Orig1s006ltr.pdf
11/16/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
06/02/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 200534

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/2024/200534s014lbl.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200534s013lbl.pdf
12/15/2023	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200534s013lbl.pdf
07/21/2021	SUPPL-10	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s011lbl.pdf
10/07/2019	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf
10/07/2019	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200534s009lbl.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf
09/18/2018	SUPPL-7	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200534s007s008lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200534s006lbl.pdf
10/20/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200534s000lbl.pdf

Therapeutic Equivalents for NDA 200534

OXYCODONE HYDROCHLORIDE

CAPSULE;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	205177	ANI PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	202773	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	Yes	AB	200534	GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	CAPSULE;ORAL	Prescription	No	AB	204752	NOVEL LABS INC

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