APPLICATION
ANDA087637
TYPE
ANDA
ORIGINAL APPROVAL
1982-08-09
LATEST ACTION
2000-02-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
TROPICAMIDEDiscontinued
TROPICAMIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2000-02-09Manufacturing (CMC) · Supplement 10AP
1996-02-13Manufacturing (CMC) · Supplement 9AP
1992-06-10Labeling · Supplement 7AP
1992-06-10Manufacturing (CMC) · Supplement 8AP
1992-06-10Manufacturing (CMC) · Supplement 6AP
1988-10-31Manufacturing (CMC) · Supplement 5AP
1988-10-31Manufacturing (CMC) · Supplement 4AP
1982-08-09OriginalAP
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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