APPLICATION
ANDA081043
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-24
LATEST ACTION
1999-06-11
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
PREDNISOLONE SODIUM PHOSPHATEDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 0.11% PHOSPHATE · SOLUTION/DROPS · OPHTHALMIC
Approval history
1999-06-11Manufacturing (CMC) · Supplement 9AP
1999-02-19Manufacturing (CMC) · Supplement 7AP
1999-02-02Manufacturing (CMC) · Supplement 6AP
1996-12-04Manufacturing (CMC) · Supplement 5AP
1996-05-31Manufacturing (CMC) · Supplement 4AP
1996-04-16Manufacturing (CMC) · Supplement 3AP
1994-06-10Labeling · Supplement 1AP
1993-12-02Labeling · Supplement 2AP
1991-10-24OriginalAP
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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