FDA NDA · NDA022308

BESIVANCE

besifloxacin

Sponsor: BAUSCH AND LOMB

APPLICATION

NDA022308

TYPE

NDA

ORIGINAL APPROVAL

2009-05-28

LATEST ACTION

2018-04-03

ROUTE

OPHTHALMIC

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Prescription

Products

BESIVANCE · ReferencePrescription

BESIFLOXACIN HYDROCHLORIDE EQ 0.6% BASE · SUSPENSION/DROPS · OPHTHALMIC

2018-04-03Labeling · Supplement 13 · standard — Label ↗AP

2015-11-10Manufacturing (CMC) · Supplement 11 · standardAP

2015-04-07Manufacturing (CMC) · Supplement 10 · standardAP

2014-09-05Manufacturing (CMC) · Supplement 9 · standardAP

2014-04-30Manufacturing (CMC) · Supplement 8 · standardAP

2013-11-14Manufacturing (CMC) · Supplement 7 · standardAP

2013-08-16Manufacturing (CMC) · Supplement 5 · standardAP

2013-05-10Manufacturing (CMC) · Supplement 6 · standardAP

2012-09-18Efficacy · Supplement 3 · standard — Label ↗AP

2009-05-28Type 1 - New Molecular Entity · Original · standard — Label ↗AP

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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