Sincalide
These highlights do not include all the information needed to use SINCALIDE FOR INJECTION safely and effectively. See full prescribing information for SINCALIDE FOR INJECTION SINCALIDE for injection, for intravenous use Initial U.S. Approval: 1976
Approved
Approval ID
4149af34-7b3d-4200-9609-ea856b1d6aab
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2023
Manufacturers
FDA
MAIA Pharmaceuticals, Inc.
DUNS: 079211845
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sincalide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70511-131
Application NumberNDA210850
Product Classification
M
Marketing Category
C73594
G
Generic Name
Sincalide
Product Specifications
Route of AdministrationINTRAVENOUS
Effective DateNovember 1, 2023
FDA Product Classification
INGREDIENTS (7)
SINCALIDEActive
Quantity: 5 ug in 5 mL
Code: M03GIQ7Z6P
Classification: ACTIB
METHIONINEInactive
Quantity: 4 mg in 5 mL
Code: AE28F7PNPL
Classification: IACT
MANNITOLInactive
Quantity: 170 mg in 5 mL
Code: 3OWL53L36A
Classification: IACT
ARGININE HYDROCHLORIDEInactive
Quantity: 30 mg in 5 mL
Code: F7LTH1E20Y
Classification: IACT
LYSINE HYDROCHLORIDEInactive
Quantity: 15 mg in 5 mL
Code: JNJ23Q2COM
Classification: IACT
PENTETIC ACIDInactive
Quantity: 2 mg in 5 mL
Code: 7A314HQM0I
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: .04 mg in 5 mL
Code: 4VON5FNS3C
Classification: IACT