Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 215401

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XELSTRYM (DEXTROAMPHETAMINE)
4.5MG/9HR
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE
Proprietary Name: XELSTRYM
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 4.5MG/9HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215401
Product Number: 001
Approval Date: Mar 22, 2022
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XELSTRYM (DEXTROAMPHETAMINE)
9MG/9HR
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE
Proprietary Name: XELSTRYM
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 9MG/9HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215401
Product Number: 002
Approval Date: Mar 22, 2022
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XELSTRYM (DEXTROAMPHETAMINE)
13.5MG/9HR
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE
Proprietary Name: XELSTRYM
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 13.5MG/9HR
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N215401
Product Number: 003
Approval Date: Mar 22, 2022
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

XELSTRYM (DEXTROAMPHETAMINE)
18MG/9HR
Marketing Status: Prescription

Active Ingredient: DEXTROAMPHETAMINE
Proprietary Name: XELSTRYM
Dosage Form; Route of Administration: SYSTEM; TRANSDERMAL
Strength: 18MG/9HR
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N215401
Product Number: 004
Approval Date: Mar 22, 2022
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information