Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 205489

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COTEMPLA XR-ODT (METHYLPHENIDATE)
8.6MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: COTEMPLA XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: 8.6MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205489
Product Number: 001
Approval Date: Jun 19, 2017
Applicant Holder Full Name: NEOS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

COTEMPLA XR-ODT (METHYLPHENIDATE)
17.3MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: COTEMPLA XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: 17.3MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N205489
Product Number: 002
Approval Date: Jun 19, 2017
Applicant Holder Full Name: NEOS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information

COTEMPLA XR-ODT (METHYLPHENIDATE)
25.9MG
Marketing Status: Prescription

Active Ingredient: METHYLPHENIDATE
Proprietary Name: COTEMPLA XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: 25.9MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N205489
Product Number: 003
Approval Date: Jun 19, 2017
Applicant Holder Full Name: NEOS THERAPEUTICS INC
Marketing Status:  Prescription
Patent and Exclusivity Information