APPLICATION
ANDA074443
TYPE
ANDA
ORIGINAL APPROVAL
1995-01-30
LATEST ACTION
2002-12-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
CROLOMDiscontinued
CROMOLYN SODIUM 4% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-09Labeling · Supplement 20AP
2002-03-07Manufacturing (CMC) · Supplement 17AP
2001-11-27Manufacturing (CMC) · Supplement 19AP
2001-04-30Manufacturing (CMC) · Supplement 16AP
2001-03-07Manufacturing (CMC) · Supplement 15AP
2000-06-27Manufacturing (CMC) · Supplement 14AP
2000-05-18Manufacturing (CMC) · Supplement 11AP
2000-04-28Manufacturing (CMC) · Supplement 12AP
1999-12-27Manufacturing (CMC) · Supplement 13AP
1999-11-01Manufacturing (CMC) · Supplement 10AP
1999-06-16Labeling · Supplement 8AP
1999-06-07Manufacturing (CMC) · Supplement 9AP
1999-03-26Manufacturing (CMC) · Supplement 7AP
1998-11-19Manufacturing (CMC) · Supplement 5AP
1998-07-27Manufacturing (CMC) · Supplement 6AP
1998-03-06Manufacturing (CMC) · Supplement 2AP
1997-06-23Manufacturing (CMC) · Supplement 4AP
1997-03-25Manufacturing (CMC) · Supplement 3AP
1996-04-10Manufacturing (CMC) · Supplement 1AP
1995-01-30OriginalAP
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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