Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 022063

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MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.125MG;3.125MG;3.125MG;3.125MG
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: MYDAYIS
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3.125MG;3.125MG;3.125MG;3.125MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N022063
Product Number: 001
Approval Date: Jun 20, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
6.25MG;6.25MG;6.25MG;6.25MG
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: MYDAYIS
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 6.25MG;6.25MG;6.25MG;6.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N022063
Product Number: 002
Approval Date: Jun 20, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
9.375MG;9.375MG;9.375MG;9.375MG
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: MYDAYIS
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 9.375MG;9.375MG;9.375MG;9.375MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB2
Application Number: N022063
Product Number: 003
Approval Date: Jun 20, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information

MYDAYIS (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
12.5MG;12.5MG;12.5MG;12.5MG
Marketing Status: Prescription

Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: MYDAYIS
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 12.5MG;12.5MG;12.5MG;12.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB2
Application Number: N022063
Product Number: 004
Approval Date: Jun 20, 2017
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information