APPLICATION
NDA018155
TYPE
NDA
ORIGINAL APPROVAL
1984-10-03
LATEST ACTION
2003-03-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
OPTICROM · ReferenceDiscontinued
CROMOLYN SODIUM 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2003-03-19Labeling · Supplement 28 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 26 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 25 · standardAP
2001-07-24Manufacturing (CMC) · Supplement 23 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 24 · standardAP
2001-02-13Labeling · Supplement 22 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 21 · standardAP
1998-03-03Manufacturing (CMC) · Supplement 20 · standardAP
1993-06-11Efficacy · Supplement 18 · unknownAP
1992-10-13Manufacturing (CMC) · Supplement 16 · standardAP
1992-07-22Manufacturing (CMC) · Supplement 17 · standardAP
1990-02-09Manufacturing (CMC) · Supplement 13 · standardAP
1989-04-04Manufacturing (CMC) · Supplement 12 · standardAP
1987-09-23Manufacturing (CMC) · Supplement 11 · standardAP
1987-04-23Manufacturing (CMC) · Supplement 10 · standardAP
1987-03-12Manufacturing (CMC) · Supplement 7 · standardAP
1986-12-02Manufacturing (CMC) · Supplement 6 · standardAP
1986-10-24Manufacturing (CMC) · Supplement 8 · standardAP
1986-06-20Manufacturing (CMC) · Supplement 5 · standardAP
1985-12-23Manufacturing (CMC) · Supplement 3 · standardAP
1985-07-24Manufacturing (CMC) · Supplement 2 · standardAP
1985-06-28Manufacturing (CMC) · Supplement 4 · standardAP
1985-01-16Manufacturing (CMC) · Supplement 1 · standardAP
1984-10-03Type 3 - New Dosage Form · Original · standardAP
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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