FDA NDA · NDA020209

OXISTAT

oxiconazole nitrate

Sponsor: ANI PHARMS

APPLICATION

NDA020209

TYPE

NDA

ORIGINAL APPROVAL

1992-09-30

LATEST ACTION

2022-05-24

ROUTE

TOPICAL

DOSAGE FORM

LOTION

MARKETING STATUS

Discontinued

Products

OXISTAT · ReferenceDiscontinued

OXICONAZOLE NITRATE EQ 1% BASE · LOTION · TOPICAL

2022-05-24Labeling · Supplement 14 · standard — Letter ↗AP

2015-08-19Manufacturing (CMC) · Supplement 10 · standardAP

2015-03-03Manufacturing (CMC) · Supplement 9 · standardAP

2015-01-26Manufacturing (CMC) · Supplement 8 · standardAP

2004-01-23Labeling · Supplement 5 · standard — Letter ↗AP

1997-08-08Manufacturing (CMC) · Supplement 4 · standardAP

1993-10-21Labeling · Supplement 1 · standardAP

1992-09-30Type 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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