Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 010187

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RITALIN (METHYLPHENIDATE HYDROCHLORIDE)
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)
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)
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