APPLICATION
ANDA040064
TYPE
ANDA
ORIGINAL APPROVAL
1994-07-27
LATEST ACTION
2015-11-13
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
TROPICAMIDEPrescription
TROPICAMIDE 1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-11-13Labeling · Supplement 24 · standardAP
2001-11-27Manufacturing (CMC) · Supplement 12AP
2001-03-07Manufacturing (CMC) · Supplement 11AP
2000-10-05Manufacturing (CMC) · Supplement 10AP
2000-06-27Manufacturing (CMC) · Supplement 9AP
2000-06-02Manufacturing (CMC) · Supplement 3AP
2000-05-18Manufacturing (CMC) · Supplement 6AP
2000-05-15Manufacturing (CMC) · Supplement 8AP
2000-04-28Manufacturing (CMC) · Supplement 7AP
1999-06-07Manufacturing (CMC) · Supplement 5AP
1998-11-19Manufacturing (CMC) · Supplement 4AP
1998-02-10Manufacturing (CMC) · Supplement 2AP
1997-01-22Manufacturing (CMC) · Supplement 1AP
1994-07-27OriginalAP
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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