Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202097

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FENTANYL-100 (FENTANYL)
100MCG/HR
Marketing Status: Prescription

Active Ingredient: FENTANYL
Proprietary Name: FENTANYL-100
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 100MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202097
Product Number: 005
Approval Date: Nov 4, 2016
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FENTANYL-12 (FENTANYL)
12.5MCG/HR
Marketing Status: Prescription

Active Ingredient: FENTANYL
Proprietary Name: FENTANYL-12
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 12.5MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202097
Product Number: 001
Approval Date: Nov 4, 2016
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FENTANYL-25 (FENTANYL)
25MCG/HR
Marketing Status: Prescription

Active Ingredient: FENTANYL
Proprietary Name: FENTANYL-25
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 25MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202097
Product Number: 002
Approval Date: Nov 4, 2016
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FENTANYL-50 (FENTANYL)
50MCG/HR
Marketing Status: Prescription

Active Ingredient: FENTANYL
Proprietary Name: FENTANYL-50
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 50MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202097
Product Number: 003
Approval Date: Nov 4, 2016
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information

FENTANYL-75 (FENTANYL)
75MCG/HR
Marketing Status: Prescription

Active Ingredient: FENTANYL
Proprietary Name: FENTANYL-75
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 75MCG/HR
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A202097
Product Number: 004
Approval Date: Nov 4, 2016
Applicant Holder Full Name: KINDEVA DRUG DELIVERY LP
Marketing Status:  Prescription
Patent and Exclusivity Information