APPLICATION
ANDA089172
TYPE
ANDA
ORIGINAL APPROVAL
1990-12-28
LATEST ACTION
1996-12-04
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TROPICAMIDEDiscontinued
TROPICAMIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
1996-12-04Manufacturing (CMC) · Supplement 8AP
1996-04-16Manufacturing (CMC) · Supplement 4AP
1995-06-30Labeling · Supplement 3AP
1992-08-21Manufacturing (CMC) · Supplement 2AP
1991-10-08Manufacturing (CMC) · Supplement 1AP
1990-12-28OriginalAP
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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