FDA NDA · NDA020369

CILOXAN

ciprofloxacin hydrochloride

Sponsor: SANDOZ

APPLICATION

NDA020369

TYPE

NDA

ORIGINAL APPROVAL

1998-03-30

LATEST ACTION

2017-02-17

ROUTE

OPHTHALMIC

DOSAGE FORM

OINTMENT

MARKETING STATUS

Prescription

Products

CILOXAN · ReferencePrescription

CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE · OINTMENT · OPHTHALMIC

2017-02-17Labeling · Supplement 22 · standard — Letter ↗AP

2016-08-05Manufacturing (CMC) · Supplement 21 · standardAP

2015-09-09Manufacturing (CMC) · Supplement 20 · standardAP

2004-07-15Manufacturing (CMC) · Supplement 10 · standard — Label ↗AP

2004-07-15Labeling · Supplement 9 · standard — Letter ↗AP

2003-08-19Manufacturing (CMC) · Supplement 6 · standard — Letter ↗AP

2003-08-19Labeling · Supplement 7 · standard — Label ↗AP

2000-12-11Manufacturing (CMC) · Supplement 5 · standardAP

2000-07-07Labeling · Supplement 4 · standardAP

1999-09-28Manufacturing (CMC) · Supplement 3 · standardAP

1999-04-07Manufacturing (CMC) · Supplement 2 · standardAP

1999-02-05Manufacturing (CMC) · Supplement 1 · standardAP

1998-03-30Type 3 - New Dosage Form · Original · standard — Review ↗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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