APPLICATION
ANDA202745
TYPE
ANDA
ORIGINAL APPROVAL
2013-04-04
LATEST ACTION
2023-12-05
ROUTE
ORAL
DOSAGE FORM
CONCENTRATE
MARKETING STATUS
Prescription
Products
CROMOLYN SODIUMPrescription
CROMOLYN SODIUM 100MG/5ML · CONCENTRATE · ORAL
Approval history
2023-12-05Manufacturing (CMC) · Supplement 10 · unknownAP
2023-11-14Labeling · Supplement 2 · standardAP
2013-04-04UNKNOWN · OriginalAP
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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