sirolimus
These highlights do not include all the information needed to use SIROLIMUS ORAL SOLUTION safely and effectively. See full prescribing information for SIROLIMUS ORAL SOLUTION. SIROLIMUS oral solution Initial U.S. Approval: 1999
Approved
Approval ID
580c1ec1-c1f5-45f6-89b7-3be25c07a0e5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sirolimus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code72205-099
Application NumberANDA216728
Product Classification
M
Marketing Category
C73584
G
Generic Name
sirolimus
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 14, 2023
FDA Product Classification
INGREDIENTS (3)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SIROLIMUSActive
Quantity: 1 mg in 1 mL
Code: W36ZG6FT64
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT