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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 209905

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EVEKEO ODT (AMPHETAMINE SULFATE)
2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: EVEKEO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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: N209905
Product Number: 005
Approval Date: Apr 16, 2021
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EVEKEO ODT (AMPHETAMINE SULFATE)
5MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: EVEKEO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 5MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209905
Product Number: 001
Approval Date: Jan 30, 2019
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EVEKEO ODT (AMPHETAMINE SULFATE)
10MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: EVEKEO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209905
Product Number: 002
Approval Date: Jan 30, 2019
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EVEKEO ODT (AMPHETAMINE SULFATE)
15MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: EVEKEO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 15MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209905
Product Number: 003
Approval Date: Jan 30, 2019
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
EVEKEO ODT (AMPHETAMINE SULFATE)
20MG
Marketing Status: Discontinued
Active Ingredient: AMPHETAMINE SULFATE
Proprietary Name: EVEKEO ODT
Dosage Form; Route of Administration: TABLET, ORALLY DISINTEGRATING; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N209905
Product Number: 004
Approval Date: Jan 30, 2019
Applicant Holder Full Name: AZURITY PHARMACEUTICALS INC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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