An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

New Drug Application (NDA): 206544
Company: OHEMO LIFE

Medication Guide

REMS

FDA has determined that this product has abuse-deterrent properties

Summary Review

Products on NDA 206544

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 206544

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/02/2015	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206544lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/206544Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/206544Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-12	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/206544Orig1s012ltr.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf
12/31/2018	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s009ltr.pdf
09/18/2018	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s008s010ltr.pdf
06/01/2018	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/206544Orig1s007ltr.pdf
05/26/2017	SUPPL-6	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/206544Orig1s006ltr.pdf
12/16/2016	SUPPL-5	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf
09/30/2016	SUPPL-4	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s004ltr.pdf
12/16/2016	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s002,s005ltr.pdf
04/20/2016	SUPPL-1	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206544Orig1s001ltr.pdf

Labels for NDA 206544

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-12	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf
10/07/2019	SUPPL-12	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/206544s012lbl.pdf
12/31/2018	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s009lbl.pdf
09/18/2018	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf
09/18/2018	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s008s010lbl.pdf
06/01/2018	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/206544s007lbl.pdf
12/16/2016	SUPPL-5	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf
12/16/2016	SUPPL-2	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf
12/16/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206544s002s005lbl.pdf
10/02/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/206544lbl.pdf

Top