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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 021977

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VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
10MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 007
Approval Date: Oct 30, 2014
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
20MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 004
Approval Date: Dec 10, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
30MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 001
Approval Date: Feb 23, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
40MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 005
Approval Date: Dec 10, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
50MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 002
Approval Date: Feb 23, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
60MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 60MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N021977
Product Number: 006
Approval Date: Dec 10, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
VYVANSE (LISDEXAMFETAMINE DIMESYLATE)
70MG
Marketing Status: Prescription
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: VYVANSE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 70MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N021977
Product Number: 003
Approval Date: Feb 23, 2007
Applicant Holder Full Name: TAKEDA PHARMACEUTICALS USA INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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