APPLICATION
ANDA074850
TYPE
ANDA
ORIGINAL APPROVAL
1996-10-28
LATEST ACTION
2005-04-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued
Products
LEVOBUNOLOL HYDROCHLORIDEDiscontinued
LEVOBUNOLOL HYDROCHLORIDE 0.5% · SOLUTION/DROPS · OPHTHALMIC
Approval history
2005-04-08Labeling · Supplement 13AP
2002-12-23Manufacturing (CMC) · Supplement 12AP
2002-10-29Labeling · Supplement 10AP
2002-10-01Manufacturing (CMC) · Supplement 11AP
2002-08-02Manufacturing (CMC) · Supplement 8AP
2002-03-27Manufacturing (CMC) · Supplement 9AP
2000-04-28Manufacturing (CMC) · Supplement 6AP
2000-04-07Manufacturing (CMC) · Supplement 7AP
1999-05-07Manufacturing (CMC) · Supplement 3AP
1999-03-23Manufacturing (CMC) · Supplement 5AP
1999-03-04Manufacturing (CMC) · Supplement 2AP
1999-01-21Manufacturing (CMC) · Supplement 4AP
1998-06-04Manufacturing (CMC) · Supplement 1AP
1996-10-28OriginalAP
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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