FDA NDA · NDA020805

CIPROFLOXACIN HYDROCHLORIDE AND HYDROCORTISONE

Sponsor: SANDOZ

APPLICATION

NDA020805

TYPE

NDA

ORIGINAL APPROVAL

1998-02-10

LATEST ACTION

2017-03-20

ROUTE

AURICULAR (OTIC), OTIC

DOSAGE FORM

SUSPENSION/DROPS

MARKETING STATUS

Prescription

Products

CIPRO HC · ReferencePrescription

CIPROFLOXACIN HYDROCHLORIDE EQ 0.2% BASE, HYDROCORTISONE 1% · SUSPENSION/DROPS · OTIC

2017-03-20Labeling · Supplement 11 · standard — Label ↗AP

2013-07-09Manufacturing (CMC) · Supplement 10 · standardAP

2002-03-13Manufacturing (CMC) · Supplement 6 · standardAP

2001-04-19Manufacturing (CMC) · Supplement 5 · standardAP

2001-02-27Manufacturing (CMC) · Supplement 4 · standardAP

1999-10-14Labeling · Supplement 3 · standardAP

1998-09-17Manufacturing (CMC) · Supplement 2 · standardAP

1998-09-15Manufacturing (CMC) · Supplement 1 · standardAP

1998-02-10Type 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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