← FDA DRUG APPROVALS

FDA ANDA · ANDA216063

TOLVAPTAN

Sponsor: LUPIN

APPLICATION
ANDA216063
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-23
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TOLVAPTANPrescription
TOLVAPTAN 60MG · TABLET · ORAL
TOLVAPTANPrescription
TOLVAPTAN 30MG · TABLET · ORAL
TOLVAPTANPrescription
TOLVAPTAN 90MG · TABLET · ORAL
TOLVAPTANPrescription
TOLVAPTAN 45MG · TABLET · ORAL
TOLVAPTANPrescription
TOLVAPTAN 15MG · TABLET · ORAL

Approval history

2025-04-23UNKNOWN · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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