APPLICATION
ANDA075282
TYPE
ANDA
ORIGINAL APPROVAL
1999-06-16
LATEST ACTION
2002-12-23
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
CROMOLYN SODIUMPrescription
CROMOLYN SODIUM 4% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-23Manufacturing (CMC) · Supplement 5AP
2002-10-01Manufacturing (CMC) · Supplement 4AP
2002-03-28Manufacturing (CMC) · Supplement 3AP
2000-04-07Manufacturing (CMC) · Supplement 2AP
1999-10-07Manufacturing (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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