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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 011522

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ADDERALL 10 (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2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 10
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;2.5MG;2.5MG;2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 007
Approval Date: Feb 13, 1996
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 12.5 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 12.5
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.125MG;3.125MG;3.125MG;3.125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 012
Approval Date: Aug 31, 2000
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 15 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 15
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.75MG;3.75MG;3.75MG;3.75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 013
Approval Date: Aug 31, 2000
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 20 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 20
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;5MG;5MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 008
Approval Date: Feb 13, 1996
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 30 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 30
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG;7.5MG;7.5MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 010
Approval Date: May 12, 1997
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 5 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 5
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG;1.25MG;1.25MG;1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 009
Approval Date: May 12, 1997
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
ADDERALL 7.5 (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: ADDERALL 7.5
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.875MG;1.875MG;1.875MG;1.875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N011522
Product Number: 011
Approval Date: Aug 31, 2000
Applicant Holder Full Name: TEVA WOMENS HEALTH INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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