Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 216063

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TOLVAPTAN (TOLVAPTAN)
15MG
Marketing Status: Prescription

Active Ingredient: TOLVAPTAN
Proprietary Name: TOLVAPTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 15MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A216063
Product Number: 001
Approval Date: Apr 23, 2025
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TOLVAPTAN (TOLVAPTAN)
30MG
Marketing Status: Prescription

Active Ingredient: TOLVAPTAN
Proprietary Name: TOLVAPTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 30MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A216063
Product Number: 002
Approval Date: Apr 23, 2025
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TOLVAPTAN (TOLVAPTAN)
45MG
Marketing Status: Prescription

Active Ingredient: TOLVAPTAN
Proprietary Name: TOLVAPTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 45MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216063
Product Number: 003
Approval Date: Apr 23, 2025
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TOLVAPTAN (TOLVAPTAN)
60MG
Marketing Status: Prescription

Active Ingredient: TOLVAPTAN
Proprietary Name: TOLVAPTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 60MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB2
Application Number: A216063
Product Number: 004
Approval Date: Apr 23, 2025
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information

TOLVAPTAN (TOLVAPTAN)
90MG
Marketing Status: Prescription

Active Ingredient: TOLVAPTAN
Proprietary Name: TOLVAPTAN
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 90MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A216063
Product Number: 005
Approval Date: Apr 23, 2025
Applicant Holder Full Name: LUPIN LTD
Marketing Status:  Prescription
Patent and Exclusivity Information