Application 077988

Type: ANDA
Sponsor: WOODWARD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	No	No
002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION			2010-05-26
A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION			2010-05-26

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION		2010-05-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077988-001	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077988-002	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2010-05-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077988-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077988-002	AP	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077988-001	AP	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077988-002	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077988-001	AP	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077988-002	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077988-001	AP	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077988-002	AP	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Coupler LLC	519e44f4-9318-572e-e063-6394a90afe93	2026-05-12	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2cbf3c6c-318c-4dd9-ad44-a8eb9eccb0f5	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Cardinal Health 107, LLC	f1bfba3a-5b18-41c0-9084-b1f26bb93ef2	2026-04-27	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Sportpharm LLC	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	eeeb82e1-d668-418e-9716-f8bcf72f80c0	2026-04-17	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	5cbd78cd-2cd7-4882-9902-bdb7812fbc6b	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Zydus Pharmaceuticals (USA) Inc.	d1364455-1537-46d4-b093-38cca3be778f	2026-04-07	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Mylan Pharmaceuticals Inc.	737e0fac-a2d2-4053-a0d7-edbfb6248f69	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Diflucan	FLUCONAZOLE	Roerig	f694c617-3383-416c-91b6-b94fda371204	2026-04-02	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Major Pharmaceuticals	13184b13-e252-4b4d-a3e2-cfc4ad3d55b7	2026-03-19	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	f25f31a6-4bad-40fa-bced-695552e27afd	2026-02-17	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Sportpharm LLC	60f3e8af-d98f-48dd-83e6-a78315aaed22	2026-02-15	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Golden State Medical Supply, Inc.	c2c7242d-d172-4733-e053-2995a90acb2e	2026-02-10	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Sportpharm LLC	98ac5455-d26c-4780-a5a3-bf8d85917626	2026-02-09	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Glenmark Pharmaceuticals Inc., USA	3da5f41d-5200-45ac-b89d-00881237ec85	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	2c9abaee-461f-437d-adda-e96d7ae3dd01	2026-01-23	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a0f1c111-e11e-4b7e-b990-8bc271cbc940	2026-01-14	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	A-S Medication Solutions	1a8bd42a-2bce-4b41-8678-67033e7707dd	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Zhejiang Poly Pharm. Co., Ltd.	2a3ba181-5baa-5942-e063-6294a90a82b2	2026-01-07	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	AvPAK	551a5c8f-57eb-2643-12c6-7c700584b49f	2026-01-06	Warnings, Adverse reactions	Name fallback generic name: FLUCONAZOLE

Reported adverse events (FAERS/openFDA)#

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