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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021011
Company: SPECGX LLC

Medication Guide

REMS

Products on NDA 021011

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ROXICODONE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	AB	Yes	Yes
ROXICODONE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	AB	Yes	No
ROXICODONE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021011

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/31/2000	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21011ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-011_Roxicodone.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	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021011Orig1s014ltr.pdf
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021011s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021011Orig1s013ltr.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021011s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021011Orig1s011ltr.pdf
10/07/2019	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021011s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/021011Orig1s010ltr.pdf
09/18/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.pdf
09/18/2018	SUPPL-8	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/021011Orig1s008s009ltr.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021011Orig1s006ltr.pdf
05/15/2009	SUPPL-3	Labeling-Package Insert, Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s003ltr.pdf
02/20/2009	SUPPL-2	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021011s002ltr.pdf

Labels for NDA 021011

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/15/2023	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021011s013lbl.pdf
03/04/2021	SUPPL-11	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021011s011lbl.pdf
10/07/2019	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021011s010lbl.pdf
10/07/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/021011s010lbl.pdf
09/18/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf
09/18/2018	SUPPL-8	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/021011s008s009lbl.pdf
12/16/2016	SUPPL-6	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
12/16/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021011s006lbl.pdf
05/15/2009	SUPPL-3	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf
05/15/2009	SUPPL-3	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s003lbl.pdf
02/20/2009	SUPPL-2	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021011s002lbl.pdf
08/31/2000	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21011lbl.pdf

Therapeutic Equivalents for NDA 021011

ROXICODONE

TABLET;ORAL; 15MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	207418	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	15MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

TABLET;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	207418	ASCENT PHARMS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	30MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

TABLET;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	TABLET;ORAL	Prescription	No	AB	202116	ALVOGEN
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	203638	AMNEAL PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202160	AUROLIFE PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091393	AVANTHI INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090895	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	202662	EPIC PHARMA LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	204021	NOVEL LABS INC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	207119	NUVO PHARM
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	091490	RHODES PHARMS
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	076758	SPECGX LLC
OXYCODONE HYDROCHLORIDE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	No	AB	090659	SUN PHARM INDS INC
ROXICODONE	OXYCODONE HYDROCHLORIDE	5MG	TABLET;ORAL	Prescription	Yes	AB	021011	SPECGX LLC

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