Drugs@FDA: FDA Approved Drug Products

Home | Previous Page

New Drug Application (NDA): 202880
Company: PERSION
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ZOHYDRO ER HYDROCODONE BITARTRATE 10MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes Yes
ZOHYDRO ER HYDROCODONE BITARTRATE 15MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ZOHYDRO ER HYDROCODONE BITARTRATE 20MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ZOHYDRO ER HYDROCODONE BITARTRATE 30MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ZOHYDRO ER HYDROCODONE BITARTRATE 40MG CAPSULE, EXTENDED RELEASE;ORAL Prescription None Yes No
ZOHYDRO ER HYDROCODONE BITARTRATE 50MG CAPSULE, 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
10/25/2013 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202880Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202880Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/07/2019 SUPPL-19 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202880Orig1s019ltr.pdf
09/18/2018 SUPPL-15 Labeling-Package Insert, REMS Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf
09/18/2018 SUPPL-14 REMS - MODIFIED - D-N-A Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/202880Orig1s014s015ltr.pdf
05/26/2017 SUPPL-12 REMS-Proposal Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202880Orig1s012ltr.pdf
09/30/2016 SUPPL-11 REMS - MODIFIED - D-N-A Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s011ltr.pdf
12/16/2016 SUPPL-10 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf
12/16/2016 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s009,s010ltr.pdf
04/20/2016 SUPPL-7 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202880Orig1s007ltr.pdf
06/26/2015 SUPPL-6 REMS-Modified Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s006ltr.pdf
01/30/2015 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202880Orig1s003ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003SumR.pdf
08/19/2014 SUPPL-2 Labeling-Package Insert, REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202880Orig1s002ltr.pdf
09/22/2014 SUPPL-1 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/07/2019 SUPPL-19 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf
10/07/2019 SUPPL-19 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf
09/18/2018 SUPPL-15 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf
09/18/2018 SUPPL-15 REMS Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf
09/18/2018 SUPPL-14 REMS - MODIFIED - D-N-A Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.pdf
12/16/2016 SUPPL-10 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf
12/16/2016 SUPPL-9 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf
12/16/2016 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202880s009s010lbl.pdf
01/30/2015 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202880Orig1s003lbl.pdf
08/19/2014 SUPPL-2 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf
08/19/2014 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202880s002lbl.pdf
10/25/2013 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202880s000lbl.pdf

Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English