FDA NDA · NDA019616

PENETREX

Sponsor: SANOFI AVENTIS US

APPLICATION

NDA019616

TYPE

NDA

ORIGINAL APPROVAL

1991-12-31

LATEST ACTION

2002-08-21

ROUTE

ORAL

DOSAGE FORM

TABLET

MARKETING STATUS

Discontinued

Products

PENETREXDiscontinued

ENOXACIN 400MG · TABLET · ORAL

PENETREXDiscontinued

ENOXACIN 200MG · TABLET · ORAL

2002-08-21Labeling · Supplement 5 · standard — Letter ↗AP

2002-08-21Labeling · Supplement 6 · standard — Letter ↗AP

2002-08-21Labeling · Supplement 4 · standard — Letter ↗AP

2000-04-03Manufacturing (CMC) · Supplement 7 · standardAP

1997-04-24Labeling · Supplement 2 · standardAP

1996-06-03Labeling · Supplement 3 · standardAP

1995-03-10Manufacturing (CMC) · Supplement 1 · standardAP

1991-12-31Type 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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