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)
5MG Marketing Status: Prescription

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: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EVEKEO ODT (AMPHETAMINE SULFATE)
10MG Marketing Status: Prescription

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: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EVEKEO ODT (AMPHETAMINE SULFATE)
15MG Marketing Status: Prescription

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: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

EVEKEO ODT (AMPHETAMINE SULFATE)
20MG Marketing Status: Prescription

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: ARBOR PHARMACEUTICALS LLC
Marketing Status:  Prescription
Patent and Exclusivity Information

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