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`Drug Details
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`Drug Name(s)
`FDA Application No.
`
`Active Ingredient(s)
`
`Company
`Original Approval or Tentative
`Approval Date
`Chemical Type
`Review Classification
`
`ADDERALL XR 5
`(NDA) 021303
`AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE
`SACCHARATE; DEXTROAMPHETAMINE SULFATE
`SHIRE
`October 11, 2001
`
`3 New dosage form
`S Standard review drug
`
`(cid:122) Therapeutic Equivalents
`
`(cid:122) Label Information
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`(cid:122) Medication Guide11
`
`Products on Application (NDA) #021303
` Click on a column header to re-sort the table:
`
`Drug NameActive Ingredients
`
`ADDERALL
`XR 10
`
`ADDERALL
`XR 15
`
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`XR 20
`
`ADDERALL
`XR 25
`
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`XR 30
`
`ADDERALL
`XR 5
`
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`AMPHETAMINE ASPARTATE; AMPHETAMINE
`SULFATE; DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`(cid:122) Other Important Information from FDA 10
`
`Strength
`
`2.5MG; 2.5MG;
`2.5MG; 2.5MG
`
`3.75MG;
`3.75MG;
`3.75MG;
`3.75MG
`5MG; 5MG;
`5MG; 5MG
`
`6.25MG;
`6.25MG;
`6.25MG;
`6.25MG
`7.5MG; 7.5MG;
`7.5MG; 7.5MG
`
`1.25MG;
`1.25MG;
`1.25MG;
`1.25MG
`
`Dosage
`Form/Route
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`RLDTE
`Marketing
`Code
`Status
`Prescription No AB
`
`Prescription No AB
`
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`Prescription No AB
`
`Prescription No AB
`
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`CAPSULE, EXTENDED
`RELEASE;ORAL
`
`Prescription Yes AB
`
`Prescription No AB
`
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`5. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`6. http://www.fda.gov/Drugs/InformationOnDrugs/ucm075234.htm
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`8. http://www.fda.gov/Drugs/InformationOnDrugs/ucm079436.htm
`9. http://www.accessdata.fda.gov/scripts/email/cder/commentdrugcat.cfm
`10. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm
`11. http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085819.pdf
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