Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 206627
Company: PURDUE PHARMA LP

Medication Guide

FDA Press Release

Other Important Information from FDA

REMS

FDA has determined that this product has abuse-deterrent properties

Summary Review

Products on NDA 206627

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYSINGLA ER	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	Yes
HYSINGLA ER	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
HYSINGLA ER	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
HYSINGLA ER	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
HYSINGLA ER	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
HYSINGLA ER	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
HYSINGLA ER	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206627

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/20/2014	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206627s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206627Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206627Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/31/2024	SUPPL-16	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/206627Orig1s016ltr.pdf
12/15/2023	SUPPL-15	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206627s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/206627Orig1s015ltr.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206627s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/206627Orig1s012ltr.pdf
10/07/2019	SUPPL-10	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206627Orig1s010ltr.pdf
11/14/2019	SUPPL-9	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206627Orig1s009ltr.pdf
09/18/2018	SUPPL-8	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206627Orig1s007s008ltr.pdf
09/18/2018	SUPPL-7	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206627Orig1s007s008ltr.pdf
05/26/2017	SUPPL-6	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206627Orig1s006ltr.pdf
09/30/2016	SUPPL-5	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s005ltr.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s004ltr.pdf
04/20/2016	SUPPL-3	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206627Orig1s003ltr.pdf
06/26/2015	SUPPL-1	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206627Orig1s001ltr.pdf

Labels for NDA 206627

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Url
12/15/2023	SUPPL-15	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/206627s015lbl.pdf
03/04/2021	SUPPL-12	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/206627s012lbl.pdf
10/07/2019	SUPPL-10	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.pdf
10/07/2019	SUPPL-10	Labeling-Medication Guide	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.pdf
09/18/2018	SUPPL-8	Labeling-Medication Guide	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf
09/18/2018	SUPPL-8	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf
09/18/2018	SUPPL-7	REMS - MODIFIED - D-N-A	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206627s007s008lbl.pdf
12/16/2016	SUPPL-4	Labeling-Package Insert	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf
12/16/2016	SUPPL-4	Labeling-Medication Guide	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf
11/20/2014	ORIG-1	Approval	Label (PDF)	https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206627s000lbl.pdf

Therapeutic Equivalents for NDA 206627

HYSINGLA ER

TABLET, EXTENDED RELEASE;ORAL; 20MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	20MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 30MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 40MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	40MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 60MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 80MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	80MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP

TABLET, EXTENDED RELEASE;ORAL; 120MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROCODONE BITARTRATE	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	No	AB	208269	ALVOGEN
HYSINGLA ER	HYDROCODONE BITARTRATE	120MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	Yes	AB	206627	PURDUE PHARMA LP