Product Details for NDA 021802
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
15MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
25MG
Marketing Status: Prescription
30MG
Marketing Status: Prescription
35MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 001
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 001
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 002
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 002
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
15MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 004
Approval Date: Aug 1, 2006
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 004
Approval Date: Aug 1, 2006
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 003
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 003
Approval Date: May 26, 2005
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
25MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 008
Approval Date: Apr 21, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 008
Approval Date: Apr 21, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
30MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 005
Approval Date: Oct 23, 2009
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 005
Approval Date: Oct 23, 2009
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
35MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 35MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 007
Approval Date: Apr 21, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
FOCALIN XR (DEXMETHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 35MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021802
Product Number: 007
Approval Date: Apr 21, 2011
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
40MG
Marketing Status: Prescription
Active Ingredient: DEXMETHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021802
Product Number: 006
Approval Date: Aug 11, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: FOCALIN XR
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021802
Product Number: 006
Approval Date: Aug 11, 2010
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information