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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

NDC Product Code76204-025
Application NumberANDA209264
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameCromolyn Sodium Oral Solution (Concentrate)

INGREDIENTS (2)

CROMOLYN SODIUMActive
Quantity: 100 mg in 5 mL
Code: Q2WXR1I0PK
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

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Cromolyn Sodium Oral Solution (Concentrate) - FDA Drug Approval Details