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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 214347

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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.25MG;1.25MG;1.25MG;1.25MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.25MG;1.25MG;1.25MG;1.25MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 001
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
1.875MG;1.875MG;1.875MG;1.875MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 1.875MG;1.875MG;1.875MG;1.875MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 002
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
2.5MG;2.5MG;2.5MG;2.5MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 2.5MG;2.5MG;2.5MG;2.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 003
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.125MG;3.125MG;3.125MG;3.125MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.125MG;3.125MG;3.125MG;3.125MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 004
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
3.75MG;3.75MG;3.75MG;3.75MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 3.75MG;3.75MG;3.75MG;3.75MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 005
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
5MG;5MG;5MG;5MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 5MG;5MG;5MG;5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 006
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE (AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE)
7.5MG;7.5MG;7.5MG;7.5MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Proprietary Name: DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 7.5MG;7.5MG;7.5MG;7.5MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A214347
Product Number: 007
Approval Date: Nov 22, 2021
Applicant Holder Full Name: ACCORD HEALTHCARE INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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