← FDA DRUG APPROVALS

FDA NDA · NDA020090

DIFLUCAN

fluconazole

Sponsor: PFIZER

APPLICATION
NDA020090
TYPE
NDA
ORIGINAL APPROVAL
1993-12-23
LATEST ACTION
2024-02-12
ROUTE
ORAL
DOSAGE FORM
FOR SUSPENSION
MARKETING STATUS
Prescription

Products

DIFLUCAN · ReferencePrescription
FLUCONAZOLE 50MG/5ML · FOR SUSPENSION · ORAL
DIFLUCAN · ReferencePrescription
FLUCONAZOLE 200MG/5ML · FOR SUSPENSION · ORAL

Approval history

2024-02-12Labeling · Supplement 53 · standard — Letter ↗AP
2023-07-12Labeling · Supplement 55 · standard — Letter ↗AP
2023-01-17Labeling · Supplement 54 · standard — Letter ↗AP
2022-03-09Labeling · Supplement 52 · standard — Letter ↗AP
2021-10-25Labeling · Supplement 51 · standard — Label ↗AP
2020-09-08Labeling · Supplement 50 · standard — Letter ↗AP
2019-02-07Labeling · Supplement 47 · standard — Label ↗AP
2018-03-09Labeling · Supplement 46 · standard — Label ↗AP
2018-01-22Labeling · Supplement 49 · standard — Label ↗AP
2017-10-27Labeling · Supplement 48 · standard — Label ↗AP
2014-10-30Labeling · Supplement 44 · standard — Label ↗AP
2014-07-28Manufacturing (CMC) · Supplement 43AP
2014-03-24Labeling · Supplement 42 · standard — Label ↗AP
2014-01-07Manufacturing (CMC) · Supplement 41AP
2013-09-13Labeling · Supplement 40 · standard — Letter ↗AP
2011-11-16Labeling · Supplement 38 · standard — Label ↗AP
2011-06-06Labeling · Supplement 34 · unknown — Label ↗AP
2011-04-26Labeling · Supplement 36 · unknown — Letter ↗AP
2010-08-05Labeling · Supplement 31 · unknown — Label ↗AP
2008-03-31Labeling · Supplement 22 · standard — Label ↗AP
2004-10-07Labeling · Supplement 14 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 12 · standard — Label ↗AP
2004-10-07Labeling · Supplement 17 · standard — Letter ↗AP
2004-03-24Labeling · Supplement 19 · standard — Label ↗AP
2002-08-07Labeling · Supplement 15 · standard — Label ↗AP
2001-03-05Manufacturing (CMC) · Supplement 13AP
1999-02-22Labeling · Supplement 11 · standardAP
1997-08-05Labeling · Supplement 10 · standardAP
1997-02-19Labeling · Supplement 9 · standardAP
1996-08-06Labeling · Supplement 8 · standardAP
1996-07-23Labeling · Supplement 6 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 5AP
1995-02-21Labeling · Supplement 3 · standardAP
1995-02-21Labeling · Supplement 4 · standardAP
1994-06-30Labeling · Supplement 2 · standardAP
1994-03-22Labeling · Supplement 1 · standardAP
1993-12-23Type 3 - New Dosage Form · Original · standardAP
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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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