Sorbitol-Mannitol
SORBITOL-MANNITOL IRRIGATION
Approved
Approval ID
5b44e248-4b7b-4777-954a-921c7b309944
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 7, 2021
Manufacturers
FDA
ICU Medical Inc.
DUNS: 118380146
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SORBITOL and MANNITOL
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0990-7981
Application NumberNDA018316
Product Classification
M
Marketing Category
C73594
G
Generic Name
SORBITOL and MANNITOL
Product Specifications
Route of AdministrationURETHRAL
Effective DateApril 7, 2021
FDA Product Classification
INGREDIENTS (3)
SORBITOLActive
Quantity: 2.7 g in 100 mL
Code: 506T60A25R
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
MANNITOLActive
Quantity: 0.54 g in 100 mL
Code: 3OWL53L36A
Classification: ACTIB