FDA NDA · NDA020013

MAXAQUIN

Sponsor: PHARMACIA

APPLICATION

NDA020013

TYPE

NDA

ORIGINAL APPROVAL

1992-02-21

LATEST ACTION

2005-03-16

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

MAXAQUINDiscontinued

LOMEFLOXACIN HYDROCHLORIDE EQ 400MG BASE · TABLET · ORAL

2005-03-16Labeling · Supplement 15 · standard — Letter ↗AP

2004-03-06Labeling · Supplement 14 · standard — Label ↗AP

2001-10-24Labeling · Supplement 8 · standard — Label ↗AP

1999-05-06Labeling · Supplement 13 · standardAP

1999-05-06Labeling · Supplement 11 · standardAP

1999-05-06Labeling · Supplement 12 · standardAP

1997-02-20Labeling · Supplement 9 · standardAP

1996-10-09Efficacy · Supplement 7 · standardAP

1996-09-27Labeling · Supplement 6 · standardAP

1996-09-11Labeling · Supplement 10 · standardAP

1993-09-20Manufacturing (CMC) · Supplement 3 · standardAP

1993-07-21Labeling · Supplement 2 · standardAP

1992-02-21Type 1 - New Molecular Entity · 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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