Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 204326

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ADZENYS XR-ODT (AMPHETAMINE)
EQ 3.1MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 3.1MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204326
Product Number: 001
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

ADZENYS XR-ODT (AMPHETAMINE)
EQ 6.3MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 6.3MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204326
Product Number: 002
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

ADZENYS XR-ODT (AMPHETAMINE)
EQ 9.4MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 9.4MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204326
Product Number: 003
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

ADZENYS XR-ODT (AMPHETAMINE)
EQ 12.5MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 12.5MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204326
Product Number: 004
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

ADZENYS XR-ODT (AMPHETAMINE)
EQ 15.7MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 15.7MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N204326
Product Number: 005
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

ADZENYS XR-ODT (AMPHETAMINE)
EQ 18.8MG BASE Marketing Status: Prescription

Active Ingredient: AMPHETAMINE
Proprietary Name: ADZENYS XR-ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE; ORAL
Strength: EQ 18.8MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N204326
Product Number: 006
Approval Date: Jan 27, 2016
Applicant Holder Full Name: NEOS THERAPEUTICS
Marketing Status:  Prescription
Patent and Exclusivity Information

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