Product Details for NDA 010187
RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
5MG
Marketing Status: Prescription
10MG
Marketing Status: Prescription
20MG
Marketing Status: Prescription
5MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010187
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010187
Product Number: 003
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
10MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010187
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N010187
Product Number: 006
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
20MG
Marketing Status: Prescription
Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N010187
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information
Proprietary Name: RITALIN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N010187
Product Number: 010
Approval Date: Approved Prior to Jan 1, 1982
Applicant Holder Full Name: SANDOZ INC
Marketing Status: Prescription
Patent and Exclusivity Information