FDA.reportPublic FDA data

Application 019950

Type
NDA
Sponsor
PFIZER

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIFLUCAN IN SODIUM CHLORIDE 0.9%FLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)YesNo
002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)YesNo
003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)YesNo
004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)YesNo
005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)YesNo
006DIFLUCAN IN SODIUM CHLORIDE 0.9%FLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%FLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29
N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29
N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-29
N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29
N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINERFLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-08
N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%FLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2984e616aacf4f…
2026-09-14 22:38:342026-08N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2984e616aacf4f…
2026-09-14 22:38:342026-08N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-2984e616aacf4f…
2026-09-14 22:38:342026-08N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2984e616aacf4f…
2026-09-14 22:38:342026-08N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-0884e616aacf4f…
2026-09-14 22:38:342026-08N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2984e616aacf4f…
2026-08-18 06:07:402026-07N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29caaa826d4ba7…
2026-08-18 06:07:402026-07N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-08caaa826d4ba7…
2026-08-18 06:07:402026-07N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-08011fe1cb6892…
2026-02-19 14:30 UTC2026-02N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-0831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-086a471c1ec25d…
2025-08-23 18:47 UTC2025-08N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-005DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1994-07-08fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N019950-006DIFLUCAN IN SODIUM CHLORIDE 0.9%400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019950-001DIFLUCAN IN SODIUM CHLORIDE 0.9%200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019950-002DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019950-003DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONRLD1992-09-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N019950-004DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONRLD1990-01-29b8a1b40f171c…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLECoupler LLC519e44f4-9318-572e-e063-6394a90afe932026-05-12Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEREMEDYREPACK INC.2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f52026-05-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLECardinal Health 107, LLCf1bfba3a-5b18-41c0-9084-b1f26bb93ef22026-04-27Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLESportpharm LLC8a4d6d9e-02ae-42e4-83ec-f5c4e135273b2026-04-24Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.eeeb82e1-d668-418e-9716-f8bcf72f80c02026-04-17Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEPreferred Pharmaceuticals Inc.5cbd78cd-2cd7-4882-9902-bdb7812fbc6b2026-04-16Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEZydus Pharmaceuticals (USA) Inc.d1364455-1537-46d4-b093-38cca3be778f2026-04-07Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEMylan Pharmaceuticals Inc.737e0fac-a2d2-4053-a0d7-edbfb6248f692026-04-02Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
DiflucanFLUCONAZOLERoerigf694c617-3383-416c-91b6-b94fda3712042026-04-02Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEMajor Pharmaceuticals13184b13-e252-4b4d-a3e2-cfc4ad3d55b72026-03-19Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEA-S Medication Solutionsf25f31a6-4bad-40fa-bced-695552e27afd2026-02-17Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLESportpharm LLC60f3e8af-d98f-48dd-83e6-a78315aaed222026-02-15Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEGolden State Medical Supply, Inc.c2c7242d-d172-4733-e053-2995a90acb2e2026-02-10Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLESportpharm LLC98ac5455-d26c-4780-a5a3-bf8d859176262026-02-09Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEGlenmark Pharmaceuticals Inc., USA3da5f41d-5200-45ac-b89d-00881237ec852026-01-29Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEBryant Ranch Prepack2c9abaee-461f-437d-adda-e96d7ae3dd012026-01-23Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEA-S Medication Solutionsa0f1c111-e11e-4b7e-b990-8bc271cbc9402026-01-14Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEA-S Medication Solutions1a8bd42a-2bce-4b41-8678-67033e7707dd2026-01-13Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEZhejiang Poly Pharm. Co., Ltd.2a3ba181-5baa-5942-e063-6294a90a82b22026-01-07Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEAvPAK551a5c8f-57eb-2643-12c6-7c700584b49f2026-01-06Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
77484SUPPL 2024-02-13
77480SUPPL 2024-02-13
74759SUPPL 2023-07-14
74750SUPPL 2023-07-13
73244SUPPL2023-01-18
73242SUPPL2023-01-18
70512SUPPL2022-03-15
70476SUPPL2022-03-10
69138SUPPL2021-10-27
69119SUPPL2021-10-26
64538SUPPL2020-09-10
64533SUPPL2020-09-09
62436SUPPL2020-04-03
62435SUPPL2020-04-03
60816SUPPL2019-11-12
60815SUPPL2019-11-12
34130SUPPL2014-03-25
1841SUPPL2014-03-25
34129SUPPL2013-09-17
19880SUPPL2013-09-17
34128SUPPL2011-11-21
1840SUPPL2011-11-21
19879SUPPL2011-06-08
12091SUPPL2011-06-06
12092SUPPL2011-04-29
1839SUPPL2011-04-29
19878SUPPL2010-08-10
12090SUPPL2010-08-10
34127SUPPL2008-04-16
19877SUPPL2008-04-04
34126SUPPL2004-10-08
34125SUPPL2004-10-08
19875SUPPL2004-10-08
19874SUPPL2004-10-08
12088SUPPL2004-10-08
1838SUPPL2004-10-08
12089SUPPL2004-04-05
19876SUPPL2004-03-28