APPLICATION
ANDA080229
TYPE
ANDA
ORIGINAL APPROVAL
1974-03-06
LATEST ACTION
2000-04-28
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
NAPHCON FORTE · ReferenceDiscontinued
NAPHAZOLINE HYDROCHLORIDE 0.1% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2000-04-28Manufacturing (CMC) · Supplement 25AP
1999-05-07Manufacturing (CMC) · Supplement 23AP
1999-03-23Manufacturing (CMC) · Supplement 24AP
1999-03-04Manufacturing (CMC) · Supplement 22AP
1996-07-02Labeling · Supplement 17AP
1996-04-01Manufacturing (CMC) · Supplement 21AP
1996-01-25Manufacturing (CMC) · Supplement 20AP
1995-10-05Manufacturing (CMC) · Supplement 19AP
1995-08-04Manufacturing (CMC) · Supplement 18AP
1993-06-04Manufacturing (CMC) · Supplement 14AP
1993-06-04Manufacturing (CMC) · Supplement 15AP
1993-04-06Labeling · Supplement 16AP
1989-04-27Manufacturing (CMC) · Supplement 13AP
1987-08-06Manufacturing (CMC) · Supplement 10AP
1982-11-26Manufacturing (CMC) · Supplement 9AP
1982-11-26Manufacturing (CMC) · Supplement 5AP
1974-03-06OriginalAP
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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