Product Details for NDA 204326
ADZENYS XR-ODT (AMPHETAMINE)
EQ 3.1MG BASE
Marketing Status: Prescription
EQ 6.3MG BASE
Marketing Status: Prescription
EQ 9.4MG BASE
Marketing Status: Prescription
EQ 12.5MG BASE
Marketing Status: Prescription
EQ 15.7MG BASE
Marketing Status: Prescription
EQ 18.8MG BASE
Marketing Status: Prescription
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)
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
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)
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
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)
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
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)
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
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)
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
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
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