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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 022266


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NDA 022266 describes ONSOLIS, which is a drug marketed by Adalvo and is included in one NDA. There is one patent protecting this drug. Additional details are available on the ONSOLIS profile page.

The generic ingredient in ONSOLIS is fentanyl citrate. There are thirty-one drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.
Summary for 022266
Tradename:ONSOLIS
Applicant:Adalvo
Ingredient:fentanyl citrate
Patents:1

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM;BUCCALStrengthEQ 0.2MG BASE
Approval Date:Jul 16, 2009TE:RLD:No
Patent:⤷  Sign UpPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM;BUCCALStrengthEQ 0.4MG BASE
Approval Date:Jul 16, 2009TE:RLD:No
Patent:⤷  Sign UpPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FILM;BUCCALStrengthEQ 0.6MG BASE
Approval Date:Jul 16, 2009TE:RLD:No
Patent:⤷  Sign UpPatent Expiration:Jul 23, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Expired US Patents for NDA 022266

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-001 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-002 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-003 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
Adalvo ONSOLIS fentanyl citrate FILM;BUCCAL 022266-004 Jul 16, 2009 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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