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 1.

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 · 82 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
2026-02-19 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…`
2022-03-09 01:35 UTC	2022-03	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL		2004-07-29	`782e0a99824c…`

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 2 of 6 · 101 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Sportpharm LLC	8a4d6d9e-02ae-42e4-83ec-f5c4e135273b	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	eeeb82e1-d668-418e-9716-f8bcf72f80c0	2026-04-17	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	5cbd78cd-2cd7-4882-9902-bdb7812fbc6b	2026-04-16	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Zydus Pharmaceuticals (USA) Inc.	d1364455-1537-46d4-b093-38cca3be778f	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Mylan Pharmaceuticals Inc.	737e0fac-a2d2-4053-a0d7-edbfb6248f69	2026-04-02	Warnings, Adverse reactions	Name fallback brand name: Fluconazole 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 brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	f25f31a6-4bad-40fa-bced-695552e27afd	2026-02-17	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Sportpharm LLC	60f3e8af-d98f-48dd-83e6-a78315aaed22	2026-02-15	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Golden State Medical Supply, Inc.	c2c7242d-d172-4733-e053-2995a90acb2e	2026-02-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Sportpharm LLC	98ac5455-d26c-4780-a5a3-bf8d85917626	2026-02-09	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Glenmark Pharmaceuticals Inc., USA	3da5f41d-5200-45ac-b89d-00881237ec85	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	2c9abaee-461f-437d-adda-e96d7ae3dd01	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a0f1c111-e11e-4b7e-b990-8bc271cbc940	2026-01-14	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	A-S Medication Solutions	1a8bd42a-2bce-4b41-8678-67033e7707dd	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Zhejiang Poly Pharm. Co., Ltd.	2a3ba181-5baa-5942-e063-6294a90a82b2	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	AvPAK	551a5c8f-57eb-2643-12c6-7c700584b49f	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	f76bf2f7-1752-7656-e053-6394a90a8d22	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	c924c51c-ed7e-7e72-e053-2995a90adcd3	2026-01-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	BluePoint Laboratories	83bcb8fc-53f1-4d7b-b083-0905b52c6c7e	2025-12-30	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE

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