MedPath

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

NDC Product Code42571-350
Application NumberANDA213658
Marketing CategoryC73584
Route of AdministrationINTRABRONCHIAL
Effective DateMay 4, 2022
Generic NameCromolyn Sodium

INGREDIENTS (2)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
CROMOLYN SODIUMActive
Quantity: 20 mg in 2 mL
Code: Q2WXR1I0PK
Classification: ACTIB

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Cromolyn Sodium - FDA Drug Approval Details