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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
`
`ADDERALL 5
`(NDA) 011522
`AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE
`SACCHARATE; DEXTROAMPHETAMINE SULFATE
`TEVA WOMENS
`January 19, 1960
`
`Review Classification
`
`S Standard review drug
`
`(cid:122) There are no Therapeutic Equivalents
`
`(cid:122) Label Information
`
`(cid:122) Approval History, Letters, Reviews, and
`Related Documents
`
`(cid:122) Medication Guide11
`
`Products on Application (NDA) #011522
` Click on a column header to re-sort the table:
`
`(cid:122) Other Important Information from FDA 10
`
`Drug
`Name
`ADDERALL
`10
`
`Active Ingredients
`
`Strength
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`12.5
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`15
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`20
`
`ADDERALL
`30
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`5
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`ADDERALL
`7.5
`
`AMPHETAMINE ASPARTATE;
`AMPHETAMINE SULFATE;
`DEXTROAMPHETAMINE SACCHARATE;
`DEXTROAMPHETAMINE SULFATE
`
`2.5MG; 2.5MG; 2.5MG; 2.5MG
`**Federal Register determination
`that product was not discontinued
`or withdrawn for safety or efficacy
`reasons**
`3.125MG; 3.125MG; 3.125MG;
`3.125MG **Federal Register
`determination that product was not
`discontinued or withdrawn for
`safety or efficacy reasons**
`TABLET;ORAL Discontinued No None
`3.75MG; 3.75MG; 3.75MG; 3.75MG
`**Federal Register determination
`that product was not discontinued
`or withdrawn for safety or efficacy
`reasons**
`TABLET;ORAL Discontinued No None
`5MG; 5MG; 5MG; 5MG **Federal
`Register determination that product
`was not discontinued or withdrawn
`for safety or efficacy reasons**
`7.5MG; 7.5MG; 7.5MG; 7.5MG
`**Federal Register determination
`that product was not discontinued
`or withdrawn for safety or efficacy
`reasons**
`TABLET;ORAL Discontinued No None
`1.25MG; 1.25MG; 1.25MG; 1.25MG
`**Federal Register determination
`that product was not discontinued
`or withdrawn for safety or efficacy
`reasons**
`1.875MG; 1.875MG; 1.875MG;
`1.875MG **Federal Register
`determination that product was not
`discontinued or withdrawn for
`safety or efficacy reasons**
`
`RLDTE
`Marketing
`Dosage
`Status
`Form/Route
`Code
`TABLET;ORAL Discontinued No None
`
`TABLET;ORAL Discontinued No None
`
`TABLET;ORAL Discontinued No None
`
`TABLET;ORAL Discontinued No None
`
`Amerigen Ex. 1021, p. 1
`3/19/2016
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Drug...
`
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`Drugs@FDA: FDA Approved Drug Products
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`Amerigen Ex. 1021, p. 2
`3/19/2016
`https://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Drug...