Product Details for NDA 020747
ACTIQ (FENTANYL CITRATE)
EQ 0.2MG BASE
Marketing Status: Prescription
EQ 0.4MG BASE
Marketing Status: Prescription
EQ 0.6MG BASE
Marketing Status: Prescription
EQ 0.8MG BASE
Marketing Status: Prescription
EQ 1.2MG BASE
Marketing Status: Prescription
EQ 1.6MG BASE
Marketing Status: Prescription
EQ 0.2MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 001
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTIQ (FENTANYL CITRATE)
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 001
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.4MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020747
Product Number: 002
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTIQ (FENTANYL CITRATE)
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.4MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N020747
Product Number: 002
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.6MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 003
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTIQ (FENTANYL CITRATE)
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 003
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 0.8MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 004
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTIQ (FENTANYL CITRATE)
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 0.8MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 004
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1.2MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 1.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 005
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
ACTIQ (FENTANYL CITRATE)
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 1.2MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 005
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
EQ 1.6MG BASE
Marketing Status: Prescription
Active Ingredient: FENTANYL CITRATE
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 1.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 006
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: ACTIQ
Dosage Form; Route of Administration: TROCHE/LOZENGE; TRANSMUCOSAL
Strength: EQ 1.6MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code:
Application Number: N020747
Product Number: 006
Approval Date: Nov 4, 1998
Applicant Holder Full Name: CEPHALON LLC
Marketing Status: Prescription
Patent and Exclusivity Information