Application 076246

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE	FLUCONAZOLE	FOR SUSPENSION;ORAL	50MG/5ML	No	No
002	FLUCONAZOLE	FLUCONAZOLE	FOR SUSPENSION;ORAL	200MG/5ML	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
A076246-001	FLUCONAZOLE	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL			2004-07-29
A076246-002	FLUCONAZOLE	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL			2004-07-29

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 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	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	AB	2004-07-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	AB	2004-07-29	`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	A076246-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076246-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A076246-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076246-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076246-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076246-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076246-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076246-002	AB	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 4 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Direct_Rx	06f8f4b9-5289-2d59-e063-6294a90a7209	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Slate Run Pharmaceuticals	13804efd-7cb3-431f-a6a7-bd6d1da5889e	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	direct rx	b3db505a-9677-6f5a-e053-2a95a90a13d4	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: FLUCONAZOLE generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	068623f9-0f87-50bc-e063-6294a90aea00	2025-01-14	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals, Inc.	2b9b08b6-7239-473b-e063-6294a90ab7c4	2025-01-13	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Hospira, Inc	22ebc3fb-ee81-44bd-a6e3-5e759ee724a8	2024-12-05	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	177322f4-9526-40cb-9e5d-bc24e8fb02db	2024-11-18	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Aurobindo Pharma Limited	6ebf24fd-41cd-4b3c-8176-a1436253ba2d	2024-11-14	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	4eaf5b04-c026-4a49-879f-2925b375f903	2024-11-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	Chartwell RX, LLC	f86ea347-78f5-43b8-9574-a52569a4237b	2024-10-28	Warnings, Adverse reactions	Name fallback brand name: FLUCONAZOLE generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	c94b8ecf-249f-42d6-a030-4cfb83fddb08	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	877aea10-b019-4eeb-8a1e-e6ac583df966	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	b94ca865-ab2f-466c-9913-dde9376e4533	2024-10-08	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	6b2bc10f-21a8-422a-9ea3-ed7788ffce6b	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	a499c43e-0454-4a8c-a547-31e9816babdd	2024-10-07	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	3f743514-615e-4e78-8321-24c545a7752f	2024-09-06	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Rising Pharma Holdings, Inc.	ccbe0991-27a1-4ddb-bfc7-1b3422e53390	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NorthStar Rx LLC	afde17e7-b95b-4cd5-97eb-e361724014bd	2024-08-22	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Aurobindo Pharma Limited	bf588f7e-89de-4b4e-8d33-c1ff2be1b34e	2024-08-09	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NorthStar Rx LLC	d2acccda-8068-46c1-8562-950d7f70ee06	2024-07-04	Warnings, Adverse reactions	Name fallback brand name: Fluconazole 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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0054-0002	Fluconazole	Fluconazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0002	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0002	Fluconazole	Fluconazole	West-Ward Pharmaceuticals	ANDA	Current
0054-0002	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0003	Fluconazole	Fluconazole	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0003	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp.	ANDA	Current
0054-0003	Fluconazole	Fluconazole	West-Ward Pharmaceuticals	ANDA	Current
0054-0003	Fluconazole	Fluconazole	West-Ward Pharmaceuticals Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
8881	ORIG	2004-07-30