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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 200535
Company: GENUS LIFESCIENCES

Medication Guide

REMS

Summary Review

Products on NDA 200535

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	Yes
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	AA	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 200535

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/2010/200535s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/200535s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535s000_oxycodone_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/200535Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-23	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200535s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/200535Orig1s023ltr.pdf
12/15/2023	SUPPL-22	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200535s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/200535Orig1s022ltr.pdf
03/04/2021	SUPPL-19	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200535s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/200535Orig1s019ltr.pdf
07/21/2021	SUPPL-17	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,%20200535Orig1s017ltr.pdf
10/07/2019	SUPPL-16	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/200535Orig1s016ltr.pdf
09/18/2018	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/200535Orig1s014s015ltr.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200535s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/200535Orig1s011ltr.pdf
09/01/2015	SUPPL-10	Manufacturing (CMC)		Label is not available on this site.
06/20/2014	SUPPL-9	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf
08/22/2013	SUPPL-8	Manufacturing (CMC)	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf
10/08/2013	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/200535Orig1s006,s008ltr.pdf
01/25/2012	SUPPL-4	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/200535s004ltr.pdf

Labels for NDA 200535

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/19/2024	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/200535s023lbl.pdf
12/15/2023	SUPPL-22	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/200535s022lbl.pdf
07/21/2021	SUPPL-17	Efficacy-New Dosing Regimen	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200534s010,200535s017lbl.pdf
03/04/2021	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/200535s019lbl.pdf
10/07/2019	SUPPL-16	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf
10/07/2019	SUPPL-16	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/200535s016lbl.pdf
09/18/2018	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf
09/18/2018	SUPPL-14	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/200535s014s015lbl.pdf
12/16/2016	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/200535s011lbl.pdf
06/20/2014	SUPPL-9	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200535s009lbl.pdf
08/22/2013	SUPPL-8	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf
08/22/2013	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/200535s006s008lbl.pdf
10/20/2010	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/200535s000lbl.pdf

Therapeutic Equivalents for NDA 200535

OXYCODONE HYDROCHLORIDE

SOLUTION;ORAL; 100MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	208593	ABHAI LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211749	ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	209021	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	200535	GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206822	PHARM ASSOC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213761	QUAGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	100MG/5ML	SOLUTION;ORAL	Prescription	No	AA	209897	WES PHARMA INC

SOLUTION;ORAL; 5MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	208593	ABHAI LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	211748	ALKEM LABS LTD
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204979	ANI PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	209021	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	Yes	AA	200535	GENUS LIFESCIENCES
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	204037	HIKMA
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	206914	PHARM ASSOC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	213761	QUAGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	210758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG/5ML	SOLUTION;ORAL	Prescription	No	AA	207511	WES PHARMA INC

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