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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022266

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ONSOLIS (FENTANYL CITRATE)
EQ 0.2MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ONSOLIS
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022266
Product Number: 001
Approval Date: Jul 16, 2009
Applicant Holder Full Name: ADALVO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ONSOLIS (FENTANYL CITRATE)
EQ 0.4MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ONSOLIS
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022266
Product Number: 002
Approval Date: Jul 16, 2009
Applicant Holder Full Name: ADALVO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ONSOLIS (FENTANYL CITRATE)
EQ 0.6MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ONSOLIS
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022266
Product Number: 003
Approval Date: Jul 16, 2009
Applicant Holder Full Name: ADALVO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ONSOLIS (FENTANYL CITRATE)
EQ 0.8MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ONSOLIS
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022266
Product Number: 004
Approval Date: Jul 16, 2009
Applicant Holder Full Name: ADALVO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
ONSOLIS (FENTANYL CITRATE)
EQ 1.2MG BASE
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ONSOLIS
Dosage Form; Route of Administration: FILM; BUCCAL
Strength: EQ 1.2MG BASE
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: N022266
Product Number: 005
Approval Date: Jul 16, 2009
Applicant Holder Full Name: ADALVO LTD
Marketing Status:  Discontinued
Patent and Exclusivity Information
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