APPLICATION
ANDA207605
TYPE
ANDA
ORIGINAL APPROVAL
2020-05-19
LATEST ACTION
2022-11-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TOLVAPTANPrescription
TOLVAPTAN 30MG · TABLET · ORAL
TOLVAPTANPrescription
TOLVAPTAN 15MG · TABLET · ORAL
Approval history
2022-11-08Labeling · Supplement 2 · standardAP
2022-09-06UNKNOWN · 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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