Cromolyn Sodium Oral Solution (Concentrate)
Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL
Approved
Approval ID
d208df15-c823-6e0d-e053-2a95a90ad1be
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Ritedose Pharmaceuticals, LLC
DUNS: 968062294
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cromolyn Sodium Oral Solution (Concentrate)
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code76204-025
Application NumberANDA209264
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium Oral Solution (Concentrate)
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (2)
CROMOLYN SODIUMActive
Quantity: 100 mg in 5 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT