Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021514

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DAYTRANA (METHYLPHENIDATE)
10MG/9HR (1.1MG/HR)
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: DAYTRANA
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 10MG/9HR (1.1MG/HR)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021514
Product Number: 001
Approval Date: Apr 6, 2006
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DAYTRANA (METHYLPHENIDATE)
15MG/9HR (1.6MG/HR)
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: DAYTRANA
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 15MG/9HR (1.6MG/HR)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021514
Product Number: 002
Approval Date: Apr 6, 2006
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DAYTRANA (METHYLPHENIDATE)
20MG/9HR (2.2MG/HR)
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: DAYTRANA
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 20MG/9HR (2.2MG/HR)
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021514
Product Number: 003
Approval Date: Apr 6, 2006
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

DAYTRANA (METHYLPHENIDATE)
30MG/9HR (3.3MG/HR)
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: DAYTRANA
Dosage Form; Route of Administration: FILM, EXTENDED RELEASE; TRANSDERMAL
Strength: 30MG/9HR (3.3MG/HR)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021514
Product Number: 004
Approval Date: Apr 6, 2006
Applicant Holder Full Name: NOVEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information