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 Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022510
Product Number: 001
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABSTRAL (FENTANYL CITRATE)
EQ 0.2MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022510
Product Number: 002
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABSTRAL (FENTANYL CITRATE)
EQ 0.3MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022510
Product Number: 003
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABSTRAL (FENTANYL CITRATE)
EQ 0.4MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N022510
Product Number: 004
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABSTRAL (FENTANYL CITRATE)
EQ 0.6MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022510
Product Number: 005
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ABSTRAL (FENTANYL CITRATE)
EQ 0.8MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: ABSTRAL
Dosage Form; Route of Administration: TABLET; SUBLINGUAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N022510
Product Number: 006
Approval Date: Jan 7, 2011
Applicant Holder Full Name: SENTYNL THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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