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
9f64692d-2a18-ffcb-c572-0f218a71ca67
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 26, 2023
Manufacturers
FDA
Apotex Corp
DUNS: 845263701
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 Code60505-6197
Application NumberANDA211406
Product Classification
M
Marketing Category
C73584
G
Generic Name
SIROLIMUS
Product Specifications
Route of AdministrationORAL
Effective DateJune 26, 2023
FDA Product Classification
INGREDIENTS (9)
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
SIROLIMUSActive
Quantity: 1 mg in 1 mL
Code: W36ZG6FT64
Classification: ACTIB
ASCORBYL PALMITATEInactive
Code: QN83US2B0N
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANInactive
Code: CQD833204Z
Classification: IACT
SUNFLOWER OIL MONO/DIGLYCERIDESInactive
Code: HS7EB0C1ZH
Classification: IACT
SOYBEAN PHOSPHATIDYLCHOLINEInactive
Code: 1T6N4D9YV6
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT