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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 208603
Company: ZYLA

Medication Guide

FDA has determined that this product has abuse-deterrent properties

REMS

Products on NDA 208603

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARYMO ER	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ARYMO ER	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
ARYMO ER	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 208603

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/09/2017	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/208603Orig1s000TOC.html

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-5	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/208603Orig1s005ltr.pdf
09/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf
09/18/2018	SUPPL-3	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s003s004ltr.pdf
05/26/2017	SUPPL-2	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208603Orig1s002ltr.pdf
10/12/2018	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208603Orig1s001ltr.pdf

Labels for NDA 208603

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-5	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf
10/07/2019	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/208603s005lbl.pdf
10/12/2018	SUPPL-1	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s001lbl.pdf
09/18/2018	SUPPL-4	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf
09/18/2018	SUPPL-3	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208603s003s004lbl.pdf
01/09/2017	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208603s000lbl.pdf

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