Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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U.S. Department of Health and Human Services

Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations
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Search results from the "OB_Rx" table for query on "021303."


Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 10
Applicant: SHIRE
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Application Number: N021303
Product Number: 001
Approval Date: Oct 11, 2001
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 20
Applicant: SHIRE
Strength: 5MG;5MG;5MG;5MG
Application Number: N021303
Product Number: 002
Approval Date: Oct 11, 2001
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 30
Applicant: SHIRE
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Application Number: N021303
Product Number: 003
Approval Date: Oct 11, 2001
Reference Listed Drug Yes
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 25
Applicant: SHIRE
Strength: 6.25MG;6.25MG;6.25MG;6.25MG
Application Number: N021303
Product Number: 004
Approval Date: May 22, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 5
Applicant: SHIRE
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Application Number: N021303
Product Number: 005
Approval Date: May 22, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Dosage Form;Route: CAPSULE, EXTENDED RELEASE; ORAL
Proprietary Name: ADDERALL XR 15
Applicant: SHIRE
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Application Number: N021303
Product Number: 006
Approval Date: May 22, 2002
Reference Listed Drug No
RX/OTC/DISCN: RX
TE Code: AB
Patent and Exclusivity Info for this product: View

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FDA/Center for Drug Evaluation and Research
Office of Generic Drugs
Division of Labeling and Program Support
Update Frequency:
    Orange Book Data - Monthly
    Generic Drug Product Information & Patent Information - Daily
    Orange Book Data Updated Through April, 2013
    Patent and Generic Drug Product Data Last Updated: May 24, 2013
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