Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209311

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JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE)
20MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: JORNAY PM
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209311
Product Number: 001
Approval Date: Aug 8, 2018
Applicant Holder Full Name: IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE)
40MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: JORNAY PM
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209311
Product Number: 002
Approval Date: Aug 8, 2018
Applicant Holder Full Name: IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE)
60MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: JORNAY PM
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209311
Product Number: 003
Approval Date: Aug 8, 2018
Applicant Holder Full Name: IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE)
80MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: JORNAY PM
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 80MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209311
Product Number: 004
Approval Date: Aug 8, 2018
Applicant Holder Full Name: IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information

JORNAY PM (METHYLPHENIDATE HYDROCHLORIDE)
100MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE HYDROCHLORIDE
Proprietary Name: JORNAY PM
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 100MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N209311
Product Number: 005
Approval Date: Aug 8, 2018
Applicant Holder Full Name: IRONSHORE PHARMACEUTICALS AND DEVELOPMENT INC
Marketing Status:  Prescription
Patent and Exclusivity Information