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FDA NDA · NDA019950

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER

Sponsor: PFIZER

APPLICATION
NDA019950
TYPE
NDA
ORIGINAL APPROVAL
1990-01-29
LATEST ACTION
2024-02-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
DIFLUCAN IN SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
DIFLUCAN IN SODIUM CHLORIDE 0.9% · ReferenceDiscontinued
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
FLUCONAZOLE 400MG/200ML (2MG/ML) · INJECTABLE · INJECTION
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER · ReferenceDiscontinued
FLUCONAZOLE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION

Approval history

2024-02-12Labeling · Supplement 71 · standard — Letter ↗AP
2023-07-12Labeling · Supplement 73 · standard — Letter ↗AP
2023-01-17Labeling · Supplement 72 · standard — Letter ↗AP
2022-03-09Labeling · Supplement 70 · standard — Letter ↗AP
2021-10-25Labeling · Supplement 69 · standard — Label ↗AP
2020-09-08Labeling · Supplement 68 · standard — Letter ↗AP
2019-11-07Labeling · Supplement 67 · standard — Letter ↗AP
2019-11-07Labeling · Supplement 66 · standard — Letter ↗AP
2015-06-01Manufacturing (CMC) · Supplement 65AP
2014-07-28Manufacturing (CMC) · Supplement 63AP
2014-03-24Labeling · Supplement 62 · standard — Letter ↗AP
2013-09-13Labeling · Supplement 61 · standard — Letter ↗AP
2011-11-16Labeling · Supplement 59 · standard — Label ↗AP
2011-06-06Labeling · Supplement 56 · unknown — Label ↗AP
2011-04-26Labeling · Supplement 57 · unknown — Label ↗AP
2010-08-05Labeling · Supplement 53 · unknown — Label ↗AP
2008-03-31Labeling · Supplement 43 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 37 · standard — Label ↗AP
2004-10-07Labeling · Supplement 33 · standard — Letter ↗AP
2004-10-07Labeling · Supplement 31 · standard — Letter ↗AP
2004-03-24Labeling · Supplement 39 · standard — Label ↗AP
2002-08-07Labeling · Supplement 34 · standardAP
2001-03-05Manufacturing (CMC) · Supplement 32AP
1999-09-29Manufacturing (CMC) · Supplement 29AP
1999-09-29Manufacturing (CMC) · Supplement 30AP
1999-02-22Labeling · Supplement 28 · standardAP
1998-02-13Manufacturing (CMC) · Supplement 27AP
1997-08-05Labeling · Supplement 26 · standardAP
1997-02-19Labeling · Supplement 25 · standardAP
1996-08-06Labeling · Supplement 24 · standardAP
1996-07-23Labeling · Supplement 22 · standardAP
1995-12-22Manufacturing (CMC) · Supplement 21AP
1995-03-20Manufacturing (CMC) · Supplement 20AP
1995-03-09Manufacturing (CMC) · Supplement 19AP
1994-11-23Efficacy · Supplement 16 · standardAP
1994-08-22Manufacturing (CMC) · Supplement 17AP
1994-07-08Manufacturing (CMC) · Supplement 12AP
1994-06-30Labeling · Supplement 18 · standardAP
1993-12-30Efficacy · Supplement 4AP
1993-10-13Labeling · Supplement 10 · 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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