Application 077909

Type
ANDA
Sponsor
WOODWARD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION200MG/100ML (2MG/ML)NoNo
002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION400MG/200ML (2MG/ML)NoNo
003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLEINJECTABLE;INJECTION100MG/50ML (2MG/ML)NoNo

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26
A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26
A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINERFLUCONAZOLE100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A077909-001AP
A077909-002AP

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 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2684e616aacf4f…
2026-09-14 22:38:342026-08A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2684e616aacf4f…
2026-09-14 22:38:342026-08A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-2084e616aacf4f…
2026-08-18 06:07:402026-07A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26caaa826d4ba7…
2026-08-18 06:07:402026-07A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077909-002FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER400MG/200ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077909-003FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER100MG/50ML (2MG/ML)INJECTABLE / INJECTION2015-04-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077909-001FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER200MG/100ML (2MG/ML)INJECTABLE / INJECTIONAP2010-05-26301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A077909-001AP184e616aacf4f…
2026-09-14 22:38:342026-08A077909-002AP184e616aacf4f…
2026-08-18 06:07:402026-07A077909-001AP1caaa826d4ba7…
2026-08-18 06:07:402026-07A077909-002AP1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A077909-001AP1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077909-002AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077909-001AP131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077909-002AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077909-001AP16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077909-002AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077909-001AP1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077909-002AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077909-001AP1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077909-002AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077909-001AP103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077909-002AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077909-001AP12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077909-002AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077909-001AP15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077909-002AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077909-001AP1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077909-002AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077909-001AP1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077909-002AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077909-001AP179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077909-002AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077909-001AP1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077909-002AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077909-001AP11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077909-002AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077909-001AP18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A077909-002AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077909-001AP15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A077909-002AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A077909-001AP15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A077909-002AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A077909-001AP14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A077909-002AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A077909-001AP174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A077909-002AP174a2ff9319b5…

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 5 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FluconazoleFLUCONAZOLERising Pharma Holdings, Inc.2ca7efcd-4a8d-4139-a3eb-930afd18b13f2024-07-04Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEHikma Pharmaceuticals USA Inc.d3ca59bd-ae00-48ab-89aa-87c7f56e99892024-06-28Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEBaxter Healthcare Companycd24a261-9c15-42b4-8040-89d2dbda174e2024-06-24Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLENuCare Pharmaceuticals,Inc.715c53f0-2aea-1f24-e053-2995a90ad4632024-06-10Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEPharmasource Meds, LLCfe0cc56d-c0b6-f859-e053-6294a90ad9322024-05-28Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEZydus Lifesciences Limited0adb2f88-8a6f-4f33-9e2d-73f537e053132024-03-04Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEDirect Rx69f199fa-bb92-4837-8b12-427a1c71f6222024-01-09Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEA-S Medication Solutions2fcac0e4-4f12-42d2-b129-106b4e1000752023-12-03Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEProficient Rx LPfc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f2023-10-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FLUCONAZOLEFLUCONAZOLEAsclemed USA, Inc.3208dc64-6117-4b2d-9008-76a819cef7d72023-09-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEProficient Rx LPfa2fa2f8-f3a6-4bc0-943c-03dabd0f15812023-04-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEA-S Medication Solutions08a54805-4fdf-48fd-bc3e-e9fa38f3c6912023-02-06Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEProficient Rx LPb0aa9b22-5aef-459f-bb11-b193343eeb862023-02-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEProficient Rx LP88d9904c-0c21-4188-95e2-6479bdf359df2023-01-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEProficient Rx LPfbb1bda3-f733-4404-9c9d-46c418700c032022-08-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
FluconazoleFLUCONAZOLEAsclemed USA, Inc.56a9de97-bbb9-4210-9ace-f77317d5f33b2022-03-04Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEProficient Rx LPf232600e-70ce-4001-b9da-31442f0920b92020-03-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE
fluconazoleFLUCONAZOLEProficient Rx LP7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd32019-10-01Warnings, Adverse reactionsName fallback
generic name: FLUCONAZOLE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
69784-261Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent
69784-261Fluconazole in Sodium ChlorideFluconazole, Sodium ChlorideWoodward Pharma Services LLCANDACurrent