Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216117

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RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
18MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 18MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 001
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
27MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 27MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 002
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
36MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 36MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 003
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
45MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 45MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 004
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
54MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 54MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 005
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
63MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 63MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216117
Product Number: 006
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

RELEXXII (METHYLPHENIDATE HYDROCHLORIDE)
72MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: RELEXXII
Dosage Form; Route of Administration: TABLET, EXTENDED RELEASE; ORAL
Strength: 72MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216117
Product Number: 007
Approval Date: Jun 23, 2022
Applicant Holder Full Name: OSMOTICA PHARMACEUTICAL US LLC
Marketing Status:  Prescription
Patent and Exclusivity Information