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Details for New Drug Application (NDA): 022266

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NDA 022266 describes ONSOLIS, which is a drug marketed by Bdsi and is included in one NDA. There are two patents 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. Seventeen suppliers are listed for this compound. Additional details are available on the fentanyl citrate profile page.

Summary for NDA: 022266

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Analgesics
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:FILM;BUCCALStrengthEQ 0.2MG BASE
Approval Date:Jul 16, 2009TE:RLD:No
Patent:6,159,498Patent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?
Patent:7,579,019Patent Expiration:Jan 22, 2020Product Flag?Substance Flag?Delist Request?
Patented Use:MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:FILM;BUCCALStrengthEQ 0.4MG BASE
Approval Date:Jul 16, 2009TE:RLD:No
Patent:6,159,498Patent Expiration:Oct 18, 2016Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022266

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-001Jul 16, 20096,159,498► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-003Jul 16, 20096,159,498► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-004Jul 16, 20096,159,498► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-005Jul 16, 20096,159,498► Subscribe
Bdsi
ONSOLIS
fentanyl citrate
FILM;BUCCAL022266-002Jul 16, 20096,159,498► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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