APPLICATION
ANDA075067
TYPE
ANDA
ORIGINAL APPROVAL
1999-07-19
LATEST ACTION
2005-01-06
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CROMOLYN SODIUMDiscontinued
CROMOLYN SODIUM 10MG/ML · SOLUTION · INHALATION
Approval history
2005-01-06Labeling · Supplement 6AP
2002-02-20Manufacturing (CMC) · Supplement 4AP
2001-04-03Manufacturing (CMC) · Supplement 3AP
2000-03-28Manufacturing (CMC) · Supplement 2AP
2000-03-28Manufacturing (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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