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Medicines · US (FDA)

FDA 2020

FDA

Tolvaptan

Approved 19 May 2020OralTablet

The FDA lists this product in 26 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: TOLVAPTAN 30MG

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

TOLVAPTAN 15MG · TabletANDA211891-003 · Prescription
TOLVAPTAN 30MG · TabletANDA211891-001 · Prescription
TOLVAPTAN 60MG · TabletANDA211891-002 · Prescription
TOLVAPTAN 60MG · TabletANDA220147-004 · Prescription
TOLVAPTAN 30MG · TabletANDA220147-002 · Prescription
TOLVAPTAN 90MG · TabletANDA220147-005 · Prescription
TOLVAPTAN 45MG · TabletANDA220147-003 · Prescription
TOLVAPTAN 15MG · TabletANDA220147-001 · Prescription
TOLVAPTAN 30MG · TabletANDA206119-002 · Prescription
TOLVAPTAN 15MG · TabletANDA206119-001 · Prescription
TOLVAPTAN 30MG · TabletANDA205646-001 · Prescription
TOLVAPTAN 15MG · TabletANDA205646-002 · Prescription
TOLVAPTAN 30MG · TabletThis page
TOLVAPTAN 15MG · TabletANDA207605-002 · Prescription

At a glance

Brand name: Tolvaptan
Route: Oral
Dosage form: Tablet
Applicant: Apotex
Status: Prescription
FDA approval: 19 May 2020
Application: ANDA207605-001

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

TOLVAPTAN 45MG · TabletANDA218381-003 · Prescription

TOLVAPTAN 15MG · TabletANDA218381-001 · Prescription

TOLVAPTAN 60MG · TabletANDA218381-004 · Prescription

TOLVAPTAN 30MG · TabletANDA218381-002 · Prescription

TOLVAPTAN 90MG · TabletANDA218381-005 · Prescription

TOLVAPTAN 30MG · TabletANDA216949-002 · Prescription

TOLVAPTAN 15MG · TabletANDA216949-001 · Prescription

TOLVAPTAN 60MG · TabletANDA216063-004 · Prescription

TOLVAPTAN 30MG · TabletANDA216063-002 · Prescription

TOLVAPTAN 90MG · TabletANDA216063-005 · Prescription

TOLVAPTAN 45MG · TabletANDA216063-003 · Prescription

TOLVAPTAN 15MG · TabletANDA216063-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA207605.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.