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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022510

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ABSTRAL (FENTANYL CITRATE)
EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 001
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ABSTRAL (FENTANYL CITRATE)
EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 002
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ABSTRAL (FENTANYL CITRATE)
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 003
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ABSTRAL (FENTANYL CITRATE)
EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 004
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ABSTRAL (FENTANYL CITRATE)
EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 005
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ABSTRAL (FENTANYL CITRATE)
EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N022510
Product Number: 006
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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