APPLICATION
NDA020258
TYPE
NDA
ORIGINAL APPROVAL
1993-07-30
LATEST ACTION
2026-03-18
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
IOPIDINE · ReferencePrescription
APRACLONIDINE HYDROCHLORIDE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-12-04Manufacturing (CMC) · Supplement 18 · priorityAP
2002-03-13Manufacturing (CMC) · Supplement 17 · priorityAP
2001-09-21Manufacturing (CMC) · Supplement 16 · priorityAP
2001-03-16Manufacturing (CMC) · Supplement 15 · priorityAP
2000-09-13Manufacturing (CMC) · Supplement 14 · priorityAP
2000-05-16Labeling · Supplement 11 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 13 · priorityAP
1999-09-28Manufacturing (CMC) · Supplement 10 · priorityAP
1999-08-17Manufacturing (CMC) · Supplement 12 · priorityAP
1999-04-07Manufacturing (CMC) · Supplement 9 · priorityAP
1999-03-11Manufacturing (CMC) · Supplement 7 · priorityAP
1999-02-05Manufacturing (CMC) · Supplement 8 · priorityAP
1998-08-04Manufacturing (CMC) · Supplement 6 · priorityAP
1998-01-15Manufacturing (CMC) · Supplement 5 · priorityAP
1997-04-09Manufacturing (CMC) · Supplement 4 · priorityAP
1996-12-17Manufacturing (CMC) · Supplement 3 · priorityAP
1995-11-01Manufacturing (CMC) · Supplement 1 · priorityAP
1995-11-01Manufacturing (CMC) · Supplement 2 · priorityAP
1993-07-30Type 3 - New Dosage Form · Original · priorityAP
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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