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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 202802

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LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
10MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 10MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 001
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
20MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 20MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 002
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
30MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 003
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
40MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 40MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 004
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
50MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 50MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 005
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
60MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 006
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE)
70MG
Marketing Status: Discontinued
Active Ingredient: LISDEXAMFETAMINE DIMESYLATE
Proprietary Name: LISDEXAMFETAMINE DIMESYLATE
Dosage Form; Route of Administration: CAPSULE; ORAL
Strength: 70MG
Reference Listed Drug: No
Reference Standard: No
TE Code: 
Application Number: A202802
Product Number: 007
Approval Date: Aug 25, 2023
Applicant Holder Full Name: ACTAVIS ELIZABETH LLC
Marketing Status:  Discontinued
Patent and Exclusivity Information
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