Application 076077

Type: ANDA
Sponsor: IVAX SUB TEVA PHARMS

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	Approval date
A076077-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29
A076077-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29
A076077-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29
A076077-004	FLUCONAZOLE	FLUCONAZOLE	200MG	TABLET / 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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076077-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076077-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076077-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A076077-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076077-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A076077-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076077-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076077-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076077-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076077-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076077-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076077-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076077-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076077-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076077-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076077-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076077-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076077-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076077-004	AB	1	`c0c555d07b60…`

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 6 · 102 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	REMEDYREPACK INC.	b5cfe0a1-f55c-41b1-8ad6-d1d0134a4d1d	2026-07-23	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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 42 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA,	ANDA	Current
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5410	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA,	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5411	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA,	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5412	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA,	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0172-5413	Fluconazole	Fluconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
10544-178	Fluconazole	Fluconazole	Blenheim Pharmacal, Inc.	ANDA	Current
33261-229	Fluconazole	Fluconazole	Aidarex Pharmaceuticals LLC	ANDA	Current
42852-003	Fluconazole	Fluconazole	Apothecary Shop Wholesale Inc.	ANDA	Current
61919-282	FLUCONAZOLE	FLUCONAZOLE	DIRECT RX	ANDA	Current
61919-419	FLUCONAZOLE	FLUCONAZOLE	DIRECT RX	ANDA	Current
61919-419	FLUCONAZOLE	FLUCONAZOLE	DIRECT RX	ANDA	Current
63187-613	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
63187-613	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
63629-8749	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
63629-8749	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
66116-481	Fluconazole	Fluconazole	MedVantx, Inc.	ANDA	Current
66116-510	Fluconazole	Fluconazole	MedVantx, Inc.	ANDA	Current
66336-570	Fluconazole	Fluconazole	Dispensing Solutions, Inc.	ANDA	Current
68788-9926	Fluconazole	Fluconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-9927	Fluconazole	Fluconazole	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-573	Fluconazole	Fluconazole	Proficient Rx LP	ANDA	Current
71335-1511	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current
71335-1511	Fluconazole	Fluconazole	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31071	ORIG	2004-07-30