APPLICATION
ANDA074326
TYPE
ANDA
ORIGINAL APPROVAL
1994-03-04
LATEST ACTION
2023-06-22
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription
Products
LEVOBUNOLOL HYDROCHLORIDEPrescription
LEVOBUNOLOL HYDROCHLORIDE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2023-06-22Labeling · Supplement 38 · standardAP
2023-06-22Labeling · Supplement 33 · standardAP
2002-12-19Labeling · Supplement 19AP
2001-11-27Manufacturing (CMC) · Supplement 18AP
2001-03-07Manufacturing (CMC) · Supplement 17AP
2000-10-05Manufacturing (CMC) · Supplement 16AP
2000-06-27Manufacturing (CMC) · Supplement 15AP
2000-05-18Manufacturing (CMC) · Supplement 12AP
2000-05-15Manufacturing (CMC) · Supplement 14AP
2000-04-28Manufacturing (CMC) · Supplement 13AP
1999-06-07Manufacturing (CMC) · Supplement 11AP
1999-03-22Manufacturing (CMC) · Supplement 10AP
1998-11-19Manufacturing (CMC) · Supplement 8AP
1998-10-08Manufacturing (CMC) · Supplement 9AP
1998-03-11Manufacturing (CMC) · Supplement 6AP
1998-01-28Manufacturing (CMC) · Supplement 7AP
1996-05-30Manufacturing (CMC) · Supplement 5AP
1995-11-22Manufacturing (CMC) · Supplement 3AP
1995-11-22Manufacturing (CMC) · Supplement 4AP
1994-05-12Manufacturing (CMC) · Supplement 1AP
1994-03-04OriginalAP
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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