FDA NDA · NDA019828

OXICONAZOLE NITRATE

Sponsor: FOUGERA PHARMS

APPLICATION

NDA019828

TYPE

NDA

ORIGINAL APPROVAL

1988-12-30

LATEST ACTION

2004-01-23

ROUTE

TOPICAL

DOSAGE FORM

CREAM

MARKETING STATUS

Prescription

Products

OXISTAT · ReferencePrescription

OXICONAZOLE NITRATE EQ 1% BASE · CREAM · TOPICAL

2004-01-23Labeling · Supplement 9 · standard — Letter ↗AP

1997-08-18Efficacy · Supplement 7 · standardAP

1997-08-18Efficacy · Supplement 3AP

1997-08-08Manufacturing (CMC) · Supplement 8 · standardAP

1994-06-07Manufacturing (CMC) · Supplement 6 · standardAP

1992-09-30Efficacy · Supplement 5 · standardAP

1989-11-28Manufacturing (CMC) · Supplement 2 · standardAP

1989-07-07Labeling · Supplement 1AP

1988-12-30Type 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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