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FDA NDA · NDA022445

SUSTOL

granisetron

Sponsor: HERON THERAPS INC

APPLICATION
NDA022445
TYPE
NDA
ORIGINAL APPROVAL
2016-08-09
LATEST ACTION
2026-02-23
ROUTE
SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

SUSTOL · ReferencePrescription
GRANISETRON 10MG/0.4ML (10MG/0.4ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2026-02-23Labeling · Supplement 14 · standard — Label ↗AP
2023-05-25Labeling · Supplement 10 · standard — Letter ↗AP
2016-08-09Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗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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