Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021947

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FENTORA (FENTANYL CITRATE)
EQ 0.1MG BASE Marketing Status: Prescription

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021947
Product Number: 001
Approval Date: Sep 25, 2006
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021947
Product Number: 002
Approval Date: Sep 25, 2006
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021947
Product Number: 003
Approval Date: Sep 25, 2006
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021947
Product Number: 004
Approval Date: Sep 25, 2006
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

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

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021947
Product Number: 005
Approval Date: Sep 25, 2006
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Prescription
Patent and Exclusivity Information

FENTORA (FENTANYL CITRATE)
EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Marketing Status: Discontinued

Active Ingredient: FENTANYL CITRATE
Proprietary Name: FENTORA
Dosage Form; Route of Administration: TABLET; BUCCAL, SUBLINGUAL
Strength: EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021947
Product Number: 006
Approval Date: Mar 2, 2007
Applicant Holder Full Name: CEPHALON INC
Marketing Status:  Discontinued
Patent and Exclusivity Information

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