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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Search results from the "OB_Rx" table for query on "021514."



Active Ingredient: METHYLPHENIDATE
Dosage Form;Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Proprietary Name: DAYTRANA
Applicant: NOVEN PHARMS INC
Strength: 10MG/9HR (1.1MG/HR)
Application Number: N021514
Product Number: 001
Approval Date: Apr 6, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: METHYLPHENIDATE
Dosage Form;Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Proprietary Name: DAYTRANA
Applicant: NOVEN PHARMS INC
Strength: 15MG/9HR (1.6MG/HR)
Application Number: N021514
Product Number: 002
Approval Date: Apr 6, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: METHYLPHENIDATE
Dosage Form;Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Proprietary Name: DAYTRANA
Applicant: NOVEN PHARMS INC
Strength: 20MG/9HR (2.2MG/HR)
Application Number: N021514
Product Number: 003
Approval Date: Apr 6, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: METHYLPHENIDATE
Dosage Form;Route: FILM, EXTENDED RELEASE;TRANSDERMAL
Proprietary Name: DAYTRANA
Applicant: NOVEN PHARMS INC
Strength: 30MG/9HR (3.3MG/HR)
Application Number: N021514
Product Number: 004
Approval Date: Apr 6, 2006
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:

Orange Book Data - Monthly
Generic Drug Product Information & Patent Information - Daily
Orange Book Data Updated Through August 2014
Patent and Generic Drug Product Data Last Updated September 29, 2014

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