APPLICATION
ANDA074209
TYPE
ANDA
ORIGINAL APPROVAL
1994-04-26
LATEST ACTION
2004-05-26
ROUTE
INHALATION
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
CROMOLYN SODIUMDiscontinued
CROMOLYN SODIUM 10MG/ML · SOLUTION · INHALATION
Approval history
2004-05-26Labeling · Supplement 14AP
2004-04-01Labeling · Supplement 12AP
2002-12-20Manufacturing (CMC) · Supplement 10AP
2002-12-20Manufacturing (CMC) · Supplement 8AP
2001-01-31Manufacturing (CMC) · Supplement 7AP
1999-06-16Labeling · Supplement 6AP
1998-12-18Labeling · Supplement 4AP
1998-05-13Manufacturing (CMC) · Supplement 3AP
1997-03-03Manufacturing (CMC) · Supplement 1AP
1994-04-26OriginalAP
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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