Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 210354

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METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
2.5MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210354
Product Number: 001
Approval Date: Dec 29, 2017
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
5MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A210354
Product Number: 002
Approval Date: Dec 29, 2017
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

METHYLPHENIDATE HYDROCHLORIDE (METHYLPHENIDATE HYDROCHLORIDE)
10MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: METHYLPHENIDATE HYDROCHLORIDE
Dosage Form; Route of Administration: TABLET, CHEWABLE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: Yes
TE Code: AB
Application Number: A210354
Product Number: 003
Approval Date: Dec 29, 2017
Applicant Holder Full Name: ASCENT PHARMACEUTICALS INC
Marketing Status:  Prescription
Patent and Exclusivity Information