Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019516
Company: KNOA PHARMA

• Medication Guide

• REMS

Products on NDA 19516

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MS CONTIN	MORPHINE SULFATE	30MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MS CONTIN	MORPHINE SULFATE	60MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MS CONTIN	MORPHINE SULFATE	15MG	TABLET, EXTENDED RELEASE;ORAL	Prescription	AB	Yes	No
MS CONTIN	MORPHINE SULFATE	100MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No
MS CONTIN	MORPHINE SULFATE	200MG	TABLET, EXTENDED RELEASE;ORAL	Discontinued	None	Yes	No

Labels for NDA 019516

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-62	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/019516s062lbl.pdf
12/15/2023	SUPPL-58	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019516s058lbl.pdf
03/04/2021	SUPPL-57	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019516s057lbl.pdf
10/07/2019	SUPPL-55	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf
10/07/2019	SUPPL-55	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019516s055lbl.pdf
09/18/2018	SUPPL-54	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf
09/18/2018	SUPPL-54	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf
09/18/2018	SUPPL-53	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019516s053s054lbl.pdf
12/16/2016	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf
12/16/2016	SUPPL-49	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019516s049lbl.pdf
10/22/2014	SUPPL-43	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516Orig1s043lbl.pdf
04/16/2014	SUPPL-42	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf
04/16/2014	SUPPL-42	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019516s042lbl.pdf
07/09/2012	SUPPL-37	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s037lbl.pdf
07/09/2012	SUPPL-36	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019516s036lbl.pdf
05/11/2010	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019516s034lbl.pdf