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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 201517
Company: CHARTWELL MOLECULAR

Medication Guide

REMS

Summary Review

Products on NDA 201517

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MORPHINE SULFATE	MORPHINE SULFATE	100MG/5ML	SOLUTION;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 201517

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/23/2011	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/2011/201517s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201517s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517_morphine_toc.html https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201517Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201517s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/201517Orig1s019ltr.pdf
12/15/2023	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/201517Orig1s018ltr.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/201517Orig1s017ltr.pdf
10/07/2019	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/201517Orig1s015ltr.pdf
09/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/201517Orig1s012s013ltr.pdf
12/16/2016	SUPPL-9	Labeling-Package Insert, Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201517Orig1s009ltr.pdf
02/22/2016	SUPPL-8	Manufacturing (CMC)		Label is not available on this site.
01/09/2017	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
07/10/2013	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 201517

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
12/22/2025	SUPPL-19	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201517s019lbl.pdf
12/22/2025	SUPPL-19	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/201517s019lbl.pdf
12/15/2023	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf
12/15/2023	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/201517s018lbl.pdf
03/04/2021	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/201517s017lbl.pdf
10/07/2019	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf
10/07/2019	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/201517s015lbl.pdf
09/18/2018	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf
09/18/2018	SUPPL-12	REMS - PROPOSAL - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/201517s012s013lbl.pdf
12/16/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf
12/16/2016	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf
12/16/2016	SUPPL-9	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201517s009lbl.pdf
06/23/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201517s000lbl.pdf

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