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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 022510
Company: SENTYNL THERAPS INC

Medication Guide

REMS

Summary Review

Products on NDA 022510

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ABSTRAL	FENTANYL CITRATE	EQ 0.1MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ABSTRAL	FENTANYL CITRATE	EQ 0.2MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ABSTRAL	FENTANYL CITRATE	EQ 0.3MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ABSTRAL	FENTANYL CITRATE	EQ 0.4MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ABSTRAL	FENTANYL CITRATE	EQ 0.6MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No
ABSTRAL	FENTANYL CITRATE	EQ 0.8MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET;SUBLINGUAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022510

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/07/2011	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/2011/022510s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510_abstral_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022510Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-18	Labeling-Package Insert, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022510Orig1s018ltr.pdf
09/07/2017	SUPPL-17	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022510Orig1s017ltr.pdf
12/16/2016	SUPPL-15	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022510Orig1s015ltr.pdf
12/24/2014	SUPPL-14	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s014ltr.pdf
11/04/2014	SUPPL-13	REMS-Modified, Labeling-Medication Guide	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022510Orig1s013ltr.pdf
10/02/2013	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
07/26/2013	SUPPL-10	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s010ltr.pdf
11/07/2013	SUPPL-7	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022510Orig1s007ltr.pdf
06/05/2012	SUPPL-5	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022510s005ltr.pdf
12/28/2011	SUPPL-3	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022510s003ltr.pdf

Labels for NDA 022510

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/07/2019	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf
10/07/2019	SUPPL-18	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022510s018lbl.pdf
12/16/2016	SUPPL-15	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf
12/16/2016	SUPPL-15	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022510s015lbl.pdf
11/04/2014	SUPPL-13	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
11/04/2014	SUPPL-13	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022510s013lbl.pdf
07/26/2013	SUPPL-10	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf
07/26/2013	SUPPL-10	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022510s010lbl.pdf
06/05/2012	SUPPL-5	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022510s005lbl.pdf
12/28/2011	SUPPL-3	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s003lbl.pdf
01/07/2011	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022510s000lbl.pdf

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