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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 "021802."



Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 5MG
Application Number: N021802
Product Number: 001
Approval Date: May 26, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 10MG
Application Number: N021802
Product Number: 002
Approval Date: May 26, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 20MG
Application Number: N021802
Product Number: 003
Approval Date: May 26, 2005
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 15MG
Application Number: N021802
Product Number: 004
Approval Date: Aug 1, 2006
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 30MG
Application Number: N021802
Product Number: 005
Approval Date: Oct 23, 2009
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 40MG
Application Number: N021802
Product Number: 006
Approval Date: Aug 11, 2010
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 35MG
Application Number: N021802
Product Number: 007
Approval Date: Apr 21, 2011
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code:
Patent and Exclusivity Info for this product: View

Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE;ORAL
Proprietary Name: FOCALIN XR
Applicant: NOVARTIS
Strength: 25MG
Application Number: N021802
Product Number: 008
Approval Date: Apr 21, 2011
Reference Listed Drug No
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 November 2014
Patent and Generic Drug Product Data Last Updated December 19, 2014

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