APPLICATION
NDA019219
TYPE
NDA
ORIGINAL APPROVAL
1985-12-19
LATEST ACTION
2017-12-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
BETAGAN · ReferencePrescription
LEVOBUNOLOL HYDROCHLORIDE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2015-12-16Manufacturing (CMC) · Supplement 28 · standardAP
2002-04-12Manufacturing (CMC) · Supplement 23 · standardAP
2001-12-04Manufacturing (CMC) · Supplement 22 · standardAP
2001-05-14Labeling · Supplement 19 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 21 · standardAP
2000-10-02Manufacturing (CMC) · Supplement 18 · standardAP
1998-05-19Manufacturing (CMC) · Supplement 17 · standardAP
1998-05-01Manufacturing (CMC) · Supplement 16 · standardAP
1998-02-12Manufacturing (CMC) · Supplement 15 · standardAP
1995-08-03Manufacturing (CMC) · Supplement 13 · standardAP
1995-06-12Manufacturing (CMC) · Supplement 14 · standardAP
1994-01-13Manufacturing (CMC) · Supplement 12 · standardAP
1992-02-03Labeling · Supplement 11AP
1990-01-31Labeling · Supplement 10AP
1989-12-06Manufacturing (CMC) · Supplement 9 · standardAP
1989-12-04Labeling · Supplement 7AP
1988-11-09Labeling · Supplement 5AP
1988-10-21Manufacturing (CMC) · Supplement 4 · standardAP
1987-09-15Manufacturing (CMC) · Supplement 2 · standardAP
1987-08-13Labeling · Supplement 3AP
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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