Application 078423

Type: ANDA
Sponsor: HARRIS PHARM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	50MG	No	No
002	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	100MG	No	No
003	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	150MG	No	No
004	FLUCONAZOLE	FLUCONAZOLE	TABLET;ORAL	200MG	No	No

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A078423-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07
A078423-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07
A078423-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07
A078423-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A078423-001	AB
A078423-002	AB
A078423-003	AB
A078423-004	AB

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 5 · 172 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	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-001	FLUCONAZOLE	50MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-002	FLUCONAZOLE	100MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-003	FLUCONAZOLE	150MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-004	FLUCONAZOLE	200MG	TABLET / ORAL	AB	2011-03-07	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078423-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078423-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078423-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078423-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078423-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078423-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078423-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078423-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078423-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078423-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078423-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078423-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078423-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078423-004	AB	1	`5bbf6a4d5a75…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	REMEDYREPACK INC.	91adb548-9875-47e9-8054-578ed8c7572e	2026-06-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Golden State Medical Supply, Inc.	c2c7242d-d172-4733-e053-2995a90acb2e	2026-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	2c9abaee-461f-437d-adda-e96d7ae3dd01	2026-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	a0f1c111-e11e-4b7e-b990-8bc271cbc940	2026-01-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	701cd91f-4f79-48a7-8fe5-a9678d7a4ac8	2025-10-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423 ndc (product): 71335-1948
Fluconazole	FLUCONAZOLE	ANI Pharmaceuticals, Inc.	8f90f169-6a72-4c33-a2af-0bc943602bc2	2025-08-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	c94b8ecf-249f-42d6-a030-4cfb83fddb08	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	877aea10-b019-4eeb-8a1e-e6ac583df966	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	b94ca865-ab2f-466c-9913-dde9376e4533	2024-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	6b2bc10f-21a8-422a-9ea3-ed7788ffce6b	2024-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423 ndc (product): 71335-1895
Fluconazole	FLUCONAZOLE	Proficient Rx LP	b0aa9b22-5aef-459f-bb11-b193343eeb86	2023-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078423 application number: ANDA078423 ndc (product): 71205-650

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 2 of 2 · 134 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
67405-602	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-602	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-602	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-602	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-603	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-603	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-603	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-603	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-604	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-604	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-604	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
67405-604	Fluconazole	Fluconazole	Harris Pharmaceutical, Inc.	ANDA	Current
68071-1863	Fluconazole	Fluconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4651	Fluconazole	Fluconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4651	Fluconazole	Fluconazole	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7045	Fluconazole	Fluconazole	Preferred Pharmaceutical Inc.	ANDA	Current
68788-7045	Fluconazole	Fluconazole	Preferred Pharmaceutical Inc.	ANDA	Current
68788-7045	Fluconazole	Fluconazole	Preferred Pharmaceutical Inc.	ANDA	Current
68788-8963	Fluconazole	Fluconazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8963	Fluconazole	Fluconazole	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-8963	Fluconazole	Fluconazole	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-0007	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70518-0007	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70518-0007	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70518-0562	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70518-0562	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70518-0562	Fluconazole	Fluconazole	REMEDYREPACK INC.	ANDA	Current
70934-501	Fluconazole	Fluconazole	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71205-094	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71205-094	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71205-094	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71205-104	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71205-104	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71205-650	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71335-0764	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-0764	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-0764	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1037	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1037	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1037	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1895	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1895	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1895	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1948	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1948	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1948	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1954	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1954	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1954	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
72789-096	Fluconazole	Fluconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-096	Fluconazole	Fluconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-096	Fluconazole	Fluconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-209	Fluconazole	Fluconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-209	Fluconazole	Fluconazole	PD-Rx Pharmaceuticals, Inc.	ANDA	Current