Application 078698

Type: ANDA
Sponsor: HIKMA FARMACEUTICA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	200MG/100ML (2MG/ML)	No	No
002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	INJECTABLE;INJECTION	400MG/200ML (2MG/ML)	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP		2012-01-30
A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	FLUCONAZOLE	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP		2012-01-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078698-001	AP
A078698-002	AP

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 · 84 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
2026-08-18 06:07:40	2026-07	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078698-001	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	200MG/100ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078698-002	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	400MG/200ML (2MG/ML)	INJECTABLE / INJECTION	AP	2012-01-30	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078698-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078698-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078698-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078698-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078698-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078698-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078698-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078698-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078698-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078698-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078698-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078698-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078698-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078698-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078698-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078698-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078698-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078698-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078698-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078698-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078698-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078698-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078698-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078698-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078698-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078698-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078698-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078698-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078698-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078698-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078698-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078698-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078698-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078698-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078698-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078698-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078698-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078698-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078698-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078698-002	AP	1	`bb7c543d1eb4…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Hikma Pharmaceuticals USA Inc.	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	2024-06-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078698 application number: ANDA078698 ndc (product): 0143-9668 ndc (product): 0143-9669

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9668	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9668	Fluconazole	Fluconazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9669	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9669	Fluconazole	Fluconazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current