← FDA DRUG APPROVALS

FDA NDA · NDA019949

DIFLUCAN

Sponsor: PFIZER

APPLICATION
NDA019949
TYPE
NDA
ORIGINAL APPROVAL
1990-01-29
LATEST ACTION
2024-02-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

DIFLUCAN · ReferencePrescription
FLUCONAZOLE 150MG · TABLET · ORAL
DIFLUCAN · ReferencePrescription
FLUCONAZOLE 100MG · TABLET · ORAL
DIFLUCAN · ReferencePrescription
FLUCONAZOLE 200MG · TABLET · ORAL
DIFLUCAN · ReferencePrescription
FLUCONAZOLE 50MG · TABLET · ORAL

Approval history

2024-02-12Labeling · Supplement 72 · standard — Letter ↗AP
2023-07-12Labeling · Supplement 74 · standard — Letter ↗AP
2023-01-17Labeling · Supplement 73 · standard — Letter ↗AP
2022-03-09Labeling · Supplement 71 · standard — Letter ↗AP
2021-10-25Labeling · Supplement 70 · standard — Label ↗AP
2020-09-08Labeling · Supplement 69 · standard — Letter ↗AP
2019-02-07Labeling · Supplement 65 · standard — Label ↗AP
2018-03-09Labeling · Supplement 64 · standard — Label ↗AP
2018-01-22Labeling · Supplement 68 · standard — Label ↗AP
2017-10-27Labeling · Supplement 67 · standard — Label ↗AP
2016-06-06Manufacturing (CMC) · Supplement 63AP
2016-05-02Manufacturing (CMC) · Supplement 62AP
2015-05-29Manufacturing (CMC) · Supplement 61AP
2014-10-30Labeling · Supplement 60 · standard — Label ↗AP
2014-07-28Manufacturing (CMC) · Supplement 59AP
2014-03-24Labeling · Supplement 58 · standard — Label ↗AP
2013-09-13Labeling · Supplement 57 · standard — Label ↗AP
2011-11-16Labeling · Supplement 55 · standard — Letter ↗AP
2011-06-06Labeling · Supplement 51 · unknown — Letter ↗AP
2011-04-26Labeling · Supplement 52 · standard — Label ↗AP
2010-08-05Labeling · Supplement 48 · unknown — Label ↗AP
2008-03-31Labeling · Supplement 41 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 32 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 30 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 35 · standard — Letter ↗AP
2004-03-24Labeling · Supplement 37 · standard — Label ↗AP
2002-08-07Labeling · Supplement 33 · standard — Letter ↗AP
2001-03-05Manufacturing (CMC) · Supplement 31AP
2000-03-01Manufacturing (CMC) · Supplement 29AP
1999-09-27Manufacturing (CMC) · Supplement 28AP
1999-02-22Labeling · Supplement 27 · standardAP
1998-02-18Manufacturing (CMC) · Supplement 26AP
1997-08-05Labeling · Supplement 25 · standardAP
1997-05-02Manufacturing (CMC) · Supplement 23AP
1997-02-19Labeling · Supplement 24 · standardAP
1996-08-06Labeling · Supplement 22 · standardAP
1996-07-23Labeling · Supplement 19 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 16AP
1995-09-11Manufacturing (CMC) · Supplement 18AP
1995-09-11Manufacturing (CMC) · Supplement 17AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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