Cromolyn Sodium
Cromolyn Sodium Inhalation Solution, USP For Oral Inhalation Use Only- Not for Injection Rx only
Approved
Approval ID
aebec664-ed80-447c-9789-0cf47c8b7429
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 4, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cromolyn Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-350
Application NumberANDA213658
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium
Product Specifications
Route of AdministrationINTRABRONCHIAL
Effective DateMay 4, 2022
FDA Product Classification
INGREDIENTS (2)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROMOLYN SODIUMActive
Quantity: 20 mg in 2 mL
Code: Q2WXR1I0PK
Classification: ACTIB