Product Details for ANDA 078873
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription
50MG
Marketing Status: Prescription
60MG
Marketing Status: Prescription
40MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 001
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 001
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information
50MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 002
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information
METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 002
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information
60MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 003
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A078873
Product Number: 003
Approval Date: Jul 19, 2012
Applicant Holder Full Name: TEVA PHARMACEUTICALS USA
Marketing Status: Prescription
Patent and Exclusivity Information