Application 076213

Type: ANDA
Sponsor: ROXANE

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
A076213-001	FLUCONAZOLE	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29
A076213-002	FLUCONAZOLE	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29
A076213-003	FLUCONAZOLE	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29
A076213-004	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	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076213-001	FLUCONAZOLE	50MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076213-002	FLUCONAZOLE	100MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076213-003	FLUCONAZOLE	150MG	TABLET / ORAL	2004-07-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076213-004	FLUCONAZOLE	200MG	TABLET / ORAL	2004-07-29	`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 3 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	124c1ffa-08fd-eca5-e063-6294a90af0e2	2025-12-17	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Radha Pharmaceuticals Inc	4616c7ad-be61-7ac0-e063-6394a90ab9ed	2025-12-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	c6be26bb-af92-405b-9908-972d6e985cf0	2025-12-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	01df20c4-7b94-044e-e063-6394a90a406a	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	PD-Rx Pharmaceuticals, Inc.	28d53f27-a0cd-4d8d-e054-00144ff8d46c	2025-10-15	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	701cd91f-4f79-48a7-8fe5-a9678d7a4ac8	2025-10-06	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Dr. Reddy's Laboratories Limited	d7fa1d79-4cd3-4a55-b74b-b31e82e616a3	2025-09-23	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fef2222c-5d61-435e-8761-d8f3d435d6d8	2025-09-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	ANI Pharmaceuticals, Inc.	8f90f169-6a72-4c33-a2af-0bc943602bc2	2025-08-08	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	American Health Packaging	d7aacee3-9d9c-4b36-b735-39bcb9edf941	2025-07-23	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Bryant Ranch Prepack	90538767-c84b-4637-8ab6-8c147315eafa	2025-06-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Coupler LLC	325d5d69-5132-79ea-e063-6294a90afdd0	2025-04-09	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	c0193e27-f1a4-4698-a6bb-3df772c16256	2025-04-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	cf6c7cca-d074-2178-e053-2a95a90a3af7	2025-02-10	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	fd7ea788-29b7-1f0b-e053-6394a90a2980	2025-02-04	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	0aacafca-baf8-9a22-e063-6394a90a2ca9	2025-02-03	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	Direct Rx	db886cfe-ea23-50c9-e053-2995a90a4d10	2025-01-22	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.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31099	ORIG	2004-07-30