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 3 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-09-29 23:25 UTC	2022-09	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076246-001	FLUCONAZOLE	50MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076246-002	FLUCONAZOLE	200MG/5ML	FOR SUSPENSION / ORAL	2004-07-29	`a50c72e98297…`

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 1 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	aaf9e5f8-048e-407c-bc11-ad4edff85c05	2026-09-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	1c82929f-934b-4df4-b24f-1e5da090fd8a	2026-09-04	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	2bd1c038-ab82-496c-8129-3182238ad1a1	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Preferred Pharmaceuticals Inc.	16b6fba0-b96f-4252-a70d-31dc61400298	2026-08-20	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	485f0414-036f-4f42-87ee-a89543ac94c1	2026-08-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	A-S Medication Solutions	7961c029-746c-48c3-888b-8f8344102873	2026-07-30	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	c89c3bbd-1170-4170-e053-2a95a90a8e41	2026-07-29	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Redpharm Drug	568d9f2f-3394-b972-e063-6394a90a8628	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	6bb386b0-9dbe-40ee-b873-5215b1905920	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	HAWAII REPACK, INC.	8aa296e2-ad8d-42f6-8b41-468e2b9cdfb8	2026-07-03	Warnings, Adverse reactions	Name fallback brand name: FLUCONAZOLE generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	St. Mary's Medical Park Pharmacy	126406ae-1fdc-df20-e063-6294a90a2718	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	67af604c-928f-468b-ba27-ad45e95d3e7e	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	7259671f-a703-4a2a-81db-9a4839b34072	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a995790a-8470-4c51-801a-69347151a6fe	2026-06-24	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Northwind Health Company, LLC	0de7211d-b8ce-214d-e063-6294a90aec41	2026-06-22	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	726daf35-4c03-464f-a814-cc0a715d6031	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	dd975843-c3e4-44f4-bb0d-33b294c1f6fb	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	91adb548-9875-47e9-8054-578ed8c7572e	2026-06-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	ASCLEMED USA INC.	2099c3a0-1911-4d4a-878a-36cf054bdd0b	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	e222031d-58f6-46d6-99f8-320b9aacf2b2	2026-05-18	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