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FDA NDA · NDA019992

CIPROFLOXACIN HYDROCHLORIDE

Sponsor: SANDOZ

APPLICATION
NDA019992
TYPE
NDA
ORIGINAL APPROVAL
1990-12-31
LATEST ACTION
2017-03-21
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

CILOXAN · ReferencePrescription
CIPROFLOXACIN HYDROCHLORIDE EQ 0.3% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2017-03-21Labeling · Supplement 26 · standard — Label ↗AP
2006-02-07Labeling · Supplement 20 · standard — Label ↗AP
2004-08-20Labeling · Supplement 19 · standard — Letter ↗AP
2002-03-13Manufacturing (CMC) · Supplement 16 · standardAP
2001-09-14Manufacturing (CMC) · Supplement 15 · standardAP
2001-03-16Manufacturing (CMC) · Supplement 14 · standardAP
2000-02-18Manufacturing (CMC) · Supplement 13 · standardAP
1999-11-09Manufacturing (CMC) · Supplement 8 · standardAP
1999-08-17Manufacturing (CMC) · Supplement 12 · standardAP
1999-03-11Manufacturing (CMC) · Supplement 10 · standardAP
1999-02-05Manufacturing (CMC) · Supplement 11 · standardAP
1998-10-14Manufacturing (CMC) · Supplement 9 · standardAP
1998-01-15Manufacturing (CMC) · Supplement 7 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 6 · standardAP
1995-11-01Manufacturing (CMC) · Supplement 5 · standardAP
1994-10-27Efficacy · Supplement 4 · standardAP
1993-10-27Manufacturing (CMC) · Supplement 2 · standardAP
1993-01-22Manufacturing (CMC) · Supplement 3 · standardAP
1992-02-12Manufacturing (CMC) · Supplement 1 · standardAP
1990-12-31Type 3 - New Dosage Form · Original · standard — Pediatric Medical Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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