APPLICATION
ANDA088771
TYPE
ANDA
ORIGINAL APPROVAL
1985-01-16
LATEST ACTION
2009-03-06
ROUTE
OPHTHALMIC, OTIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
DEXAMETHASONE SODIUM PHOSPHATEDiscontinued
DEXAMETHASONE SODIUM PHOSPHATE EQ 0.1% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC, OTIC
Approval history
2009-03-06Labeling · Supplement 24AP
2005-04-11Labeling · Supplement 22AP
1999-05-10Manufacturing (CMC) · Supplement 17AP
1999-02-19Manufacturing (CMC) · Supplement 15AP
1999-02-02Manufacturing (CMC) · Supplement 14AP
1997-07-29Manufacturing (CMC) · Supplement 13AP
1996-12-04Manufacturing (CMC) · Supplement 12AP
1996-04-16Manufacturing (CMC) · Supplement 10AP
1995-12-15Manufacturing (CMC) · Supplement 11AP
1995-01-26Labeling · Supplement 9AP
1994-02-08Labeling · Supplement 7AP
1994-02-08Labeling · Supplement 8AP
1991-09-19Labeling · Supplement 6AP
1991-09-19Labeling · Supplement 29AP
1988-08-03Manufacturing (CMC) · Supplement 5AP
1988-08-03Manufacturing (CMC) · Supplement 4AP
1986-10-14Manufacturing (CMC) · Supplement 2AP
1986-05-02Manufacturing (CMC) · Supplement 1AP
1985-01-16OriginalAP
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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