APPLICATION
NDA018634
TYPE
NDA
ORIGINAL APPROVAL
1986-12-17
LATEST ACTION
2013-08-26
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BETADINE · ReferencePrescription
POVIDONE-IODINE 5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2013-08-26Manufacturing (CMC) · Supplement 13 · standardAP
2000-02-07Manufacturing (CMC) · Supplement 6 · standardAP
1991-12-30Labeling · Supplement 4AP
1991-12-30Manufacturing (CMC) · Supplement 2 · standardAP
1989-10-27Manufacturing (CMC) · Supplement 1 · standardAP
1986-12-17Type 3 - New Dosage Form · Original · standardAP
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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