APPLICATION
ANDA075271
TYPE
ANDA
ORIGINAL APPROVAL
2000-01-18
LATEST ACTION
2025-10-02
ROUTE
INTRABRONCHIAL, INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
CROMOLYN SODIUMPrescription
CROMOLYN SODIUM 10MG/ML · SOLUTION · INHALATION
Approval history
2025-10-02Manufacturing (CMC) · Supplement 14 · unknownAP
2008-09-03Labeling · Supplement 7AP
2001-08-15Labeling · Supplement 2AP
2001-08-15Manufacturing (CMC) · Supplement 1AP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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