FDA NDA · NDA019757

CHIBROXIN

Sponsor: MERCK

APPLICATION

NDA019757

TYPE

NDA

ORIGINAL APPROVAL

1991-06-17

LATEST ACTION

2001-02-05

ROUTE

OPHTHALMIC

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Discontinued

Products

CHIBROXINDiscontinued

NORFLOXACIN 0.3% · SOLUTION/DROPS · OPHTHALMIC

2001-02-05Labeling · Supplement 10 · standard — Label ↗AP

1999-10-08Labeling · Supplement 9 · standardAP

1998-07-27Manufacturing (CMC) · Supplement 7 · standardAP

1998-02-24Manufacturing (CMC) · Supplement 8 · standardAP

1995-04-24Manufacturing (CMC) · Supplement 6 · standardAP

1993-12-22Labeling · Supplement 5 · standardAP

1993-06-30Manufacturing (CMC) · Supplement 4 · standardAP

1993-04-27Efficacy · Supplement 2 · standardAP

1992-12-11Labeling · Supplement 3 · standardAP

1992-12-11Manufacturing (CMC) · Supplement 1 · standardAP

1991-06-17Type 3 - New Dosage Form · Original · standardAP

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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