Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021121

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CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)
18MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: CONCERTA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021121
Product Number: 001
Approval Date: Aug 1, 2000
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)
27MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: CONCERTA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021121
Product Number: 004
Approval Date: Apr 1, 2002
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)
36MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: CONCERTA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N021121
Product Number: 002
Approval Date: Aug 1, 2000
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

CONCERTA (METHYLPHENIDATE HYDROCHLORIDE)
54MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: CONCERTA
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 54MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N021121
Product Number: 003
Approval Date: Dec 8, 2000
Applicant Holder Full Name: JANSSEN PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information