Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 206627
Company: PURDUE PHARMA LP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
HYSINGLA ER HYDROCODONE BITARTRATE 20MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes Yes
HYSINGLA ER HYDROCODONE BITARTRATE 30MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
HYSINGLA ER HYDROCODONE BITARTRATE 40MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
HYSINGLA ER HYDROCODONE BITARTRATE 60MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
HYSINGLA ER HYDROCODONE BITARTRATE 80MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
HYSINGLA ER HYDROCODONE BITARTRATE 100MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
HYSINGLA ER HYDROCODONE BITARTRATE 120MG TABLET, EXTENDED RELEASE;ORAL Prescription None Yes No
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
10/07/2019 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert 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
09/18/2018 SUPPL-8 Labeling-Package Insert, Labeling-Medication Guide 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-Medication Guide, Labeling-Package Insert 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
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-10 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.pdf
10/07/2019 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206627s010lbl.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-8 Labeling-Medication Guide 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-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206627s004lbl.pdf
12/16/2016 SUPPL-4 Labeling-Package Insert 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

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