APPLICATION
ANDA080248
TYPE
ANDA
ORIGINAL APPROVAL
1972-03-24
LATEST ACTION
2002-11-15
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
ALBALONDiscontinued
NAPHAZOLINE HYDROCHLORIDE 0.1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC
Approval history
2002-11-15Manufacturing (CMC) · Supplement 42AP
2002-07-03Manufacturing (CMC) · Supplement 40AP
2001-11-15Manufacturing (CMC) · Supplement 39AP
2001-08-15Manufacturing (CMC) · Supplement 38AP
2000-12-08Manufacturing (CMC) · Supplement 37AP
1999-03-18Manufacturing (CMC) · Supplement 35AP
1998-08-24Manufacturing (CMC) · Supplement 36AP
1997-09-29Manufacturing (CMC) · Supplement 33AP
1997-09-29Manufacturing (CMC) · Supplement 34AP
1995-06-21Manufacturing (CMC) · Supplement 31AP
1995-06-21Manufacturing (CMC) · Supplement 32AP
1994-09-27Manufacturing (CMC) · Supplement 30AP
1992-05-07Manufacturing (CMC) · Supplement 29AP
1991-03-25Labeling · Supplement 28AP
1988-01-20Manufacturing (CMC) · Supplement 26AP
1987-06-05Manufacturing (CMC) · Supplement 25AP
1983-05-12Manufacturing (CMC) · Supplement 20AP
1972-03-24OriginalAP
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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