APPLICATION
ANDA216933
TYPE
ANDA
ORIGINAL APPROVAL
2026-07-21
LATEST ACTION
2026-07-21
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
2026-07-21UNKNOWN · Original · standardAP
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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