APPLICATION
ANDA080235
TYPE
ANDA
ORIGINAL APPROVAL
1971-06-07
LATEST ACTION
2001-04-19
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
VASOCONDiscontinued
NAPHAZOLINE HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2001-04-19Manufacturing (CMC) · Supplement 19AP
1995-07-07Manufacturing (CMC) · Supplement 13AP
1994-10-07Manufacturing (CMC) · Supplement 14AP
1994-06-10Manufacturing (CMC) · Supplement 15AP
1992-10-08Manufacturing (CMC) · Supplement 12AP
1991-01-16Labeling · Supplement 8AP
1986-08-11Manufacturing (CMC) · Supplement 7AP
1983-03-24Manufacturing (CMC) · Supplement 5AP
1982-07-28Manufacturing (CMC) · Supplement 3AP
1982-07-28Manufacturing (CMC) · Supplement 4AP
1971-06-07OriginalAP
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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