SUSTOL
These highlights do not include all the information needed to use SUSTOL safely and effectively. See full prescribing information for SUSTOL.SUSTOL (granisetron) extended-release injection, for subcutaneous useInitial U.S. Approval: 1993
Approved
Approval ID
f7c7ffdd-8270-4030-bc1e-a1cb28a6de56
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 7, 2023
Manufacturers
FDA
Heron Therapeutics, Inc.
DUNS: 102099843
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
granisetron
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code47426-101
Application NumberNDA022445
Product Classification
M
Marketing Category
C73594
G
Generic Name
granisetron
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateMay 31, 2017
FDA Product Classification
INGREDIENTS (2)
GRANISETRONActive
Quantity: 10 mg in 0.4 mL
Code: WZG3J2MCOL
Classification: ACTIB
METHOXY PEG-10Inactive
Code: UQE3488NAI
Classification: IACT