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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021303

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ADDERALL XR 10 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
2.5MG;2.5MG;2.5MG;2.5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL XR 10
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021303
Product Number: 001
Approval Date: Oct 11, 2001
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADDERALL XR 15 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.75MG;3.75MG;3.75MG;3.75MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL XR 15
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021303
Product Number: 006
Approval Date: May 22, 2002
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADDERALL XR 20 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
5MG;5MG;5MG;5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL XR 20
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 5MG;5MG;5MG;5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021303
Product Number: 002
Approval Date: Oct 11, 2001
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADDERALL XR 25 (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: ADDERALL XR 25
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: AB1
Application Number: N021303
Product Number: 004
Approval Date: May 22, 2002
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADDERALL XR 30 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
7.5MG;7.5MG;7.5MG;7.5MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL XR 30
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB1
Application Number: N021303
Product Number: 003
Approval Date: Oct 11, 2001
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
ADDERALL XR 5 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.25MG;1.25MG;1.25MG;1.25MG
Marketing Status: Prescription
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL XR 5
Dosage Form; Route of Administration: CAPSULE, EXTENDED RELEASE; ORAL
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB1
Application Number: N021303
Product Number: 005
Approval Date: May 22, 2002
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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