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): 022266
Company: ADALVO

Medication Guide

Other Important Information from FDA

Prescriber Information

REMS

Medication Guide

Summary Review

Products on NDA 022266

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ONSOLIS	FENTANYL CITRATE	EQ 0.2MG BASE	FILM;BUCCAL	Discontinued	None	No	No
ONSOLIS	FENTANYL CITRATE	EQ 0.4MG BASE	FILM;BUCCAL	Discontinued	None	No	No
ONSOLIS	FENTANYL CITRATE	EQ 0.6MG BASE	FILM;BUCCAL	Discontinued	None	No	No
ONSOLIS	FENTANYL CITRATE	EQ 0.8MG BASE	FILM;BUCCAL	Discontinued	None	No	No
ONSOLIS	FENTANYL CITRATE	EQ 1.2MG BASE	FILM;BUCCAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 022266

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/16/2009	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/2009/022266s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022266s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266_onsolis_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022266s000_SumR_P1.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/17/2022	SUPPL-27	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/022266Orig1s027ltr.pdf
12/03/2021	SUPPL-26	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022266Orig1s026Correctedltr.pdf
03/04/2021	SUPPL-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022266Orig1s025ltr.pdf
12/23/2020	SUPPL-24	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022266Orig1s024ltr.pdf
10/07/2019	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/022266Orig1s023ltr.pdf
09/07/2017	SUPPL-19	REMS-Proposal	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022266Orig1s019ltr.pdf
12/16/2016	SUPPL-18	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf
12/16/2016	SUPPL-17	Labeling-Medication Guide, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022266Orig1s017,s018ltr.pdf
08/11/2015	SUPPL-15	Manufacturing (CMC)	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf
12/24/2014	SUPPL-14	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022266Orig1s014ltr.pdf
11/07/2013	SUPPL-12	REMS-Modified	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022266Orig1s012ltr.pdf
06/05/2012	SUPPL-9	REMS-Modified	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022266s009ltr.pdf
12/28/2011	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022266s008ltr.pdf
07/01/2010	SUPPL-1	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022266s001ltr.pdf

Labels for NDA 022266

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/04/2021	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022266s025lbl.pdf
10/07/2019	SUPPL-23	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf
10/07/2019	SUPPL-23	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/022266s023lbl.pdf
12/16/2016	SUPPL-18	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
12/16/2016	SUPPL-17	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
12/16/2016	SUPPL-17	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022266s017s018lbl.pdf
08/11/2015	SUPPL-15	Manufacturing (CMC)	Label (PDF)	This supplement type does not usually require new labeling.	https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022266s015lbl.pdf
12/24/2014	SUPPL-14	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022266s014lbl.pdf
06/05/2012	SUPPL-9	REMS-Modified	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022266s009lbl.pdf
12/28/2011	SUPPL-8	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022266s008lbl.pdf
07/01/2010	SUPPL-1	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022266s001lbl.pdf
07/16/2009	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022266s000lbl.pdf

Top