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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202880
Company: RECRO GAINESVILLE

Medication Guide

Summary Review

REMS

Products on NDA 202880

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZOHYDRO ER	HYDROCODONE BITARTRATE	10MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ZOHYDRO ER	HYDROCODONE BITARTRATE	15MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ZOHYDRO ER	HYDROCODONE BITARTRATE	20MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ZOHYDRO ER	HYDROCODONE BITARTRATE	30MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ZOHYDRO ER	HYDROCODONE BITARTRATE	40MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ZOHYDRO ER	HYDROCODONE BITARTRATE	50MG	CAPSULE, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202880

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
03/04/2021	SUPPL-20	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/202880Orig1s020ltr.pdf
10/07/2019	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide	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	REMS, Labeling-Package Insert	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-Package Insert, Labeling-Medication Guide	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.

Labels for NDA 202880

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2021	SUPPL-20	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/202880s020lbl.pdf
10/07/2019	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf
10/07/2019	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202880s019lbl.pdf
09/18/2018	SUPPL-15	REMS	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/202880s014s015lbl.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-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-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
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

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