← FDA DRUG APPROVALS

FDA NDA · NDA204441

JYNARQUE

tolvaptan

Sponsor: OTSUKA

APPLICATION
NDA204441
TYPE
NDA
ORIGINAL APPROVAL
2018-04-23
LATEST ACTION
2025-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

JYNARQUE · ReferencePrescription
TOLVAPTAN 45MG · TABLET · ORAL
JYNARQUE · ReferencePrescription
TOLVAPTAN 15MG · TABLET · ORAL
JYNARQUE · ReferencePrescription
TOLVAPTAN 60MG · TABLET · ORAL
JYNARQUE · ReferencePrescription
TOLVAPTAN 30MG · TABLET · ORAL
JYNARQUE · ReferencePrescription
TOLVAPTAN 90MG · TABLET · ORAL

Approval history

2025-04-23REMS · Supplement 14 — Letter ↗AP
2024-12-16Manufacturing (CMC) · Supplement 12 — Label ↗AP
2023-09-29REMS · Supplement 10 — Letter ↗AP
2020-11-25REMS · Supplement 9 — Letter ↗AP
2020-10-19Labeling · Supplement 8 · standard — Letter ↗AP
2019-12-03REMS · Supplement 7 — Letter ↗AP
2018-12-01REMS · Supplement 2 — Label ↗AP
2018-07-30REMS · Supplement 1 — Letter ↗AP
2018-04-23Type 10 - New Indication Submitted as Distinct NDA - Not Consolidated · Original · priority — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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