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Cromolyn Sodium Inhalation Solution

CROMOLYN SODIUM INHALATION SOLUTION, USP

Approved
Approval ID

1fecdab8-08cb-4b08-89a3-9e0180a4350f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 17, 2024

Manufacturers
FDA

VIRTUS PHARMACEUTICALS LLC

DUNS: 079659493

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Cromolyn Sodium Inhalation

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code69543-456
Application NumberANDA075437
Product Classification
M
Marketing Category
C73584
G
Generic Name
Cromolyn Sodium Inhalation
Product Specifications
Route of AdministrationINTRABRONCHIAL
Effective DateJanuary 17, 2024
FDA Product Classification

INGREDIENTS (2)

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

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Cromolyn Sodium Inhalation Solution - FDA Drug Approval Details