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 5 of 5 · 98 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Fluconazole	FLUCONAZOLE	Rising Pharma Holdings, Inc.	2ca7efcd-4a8d-4139-a3eb-930afd18b13f	2024-07-04	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Hikma Pharmaceuticals USA Inc.	d3ca59bd-ae00-48ab-89aa-87c7f56e9989	2024-06-28	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Baxter Healthcare Company	cd24a261-9c15-42b4-8040-89d2dbda174e	2024-06-24	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	NuCare Pharmaceuticals,Inc.	715c53f0-2aea-1f24-e053-2995a90ad463	2024-06-10	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Pharmasource Meds, LLC	fe0cc56d-c0b6-f859-e053-6294a90ad932	2024-05-28	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Zydus Lifesciences Limited	0adb2f88-8a6f-4f33-9e2d-73f537e05313	2024-03-04	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Direct Rx	69f199fa-bb92-4837-8b12-427a1c71f622	2024-01-09	Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	A-S Medication Solutions	2fcac0e4-4f12-42d2-b129-106b4e100075	2023-12-03	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fc4fccd8-19d2-4704-afa9-9ce0ab1d2b5f	2023-10-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
FLUCONAZOLE	FLUCONAZOLE	Asclemed USA, Inc.	3208dc64-6117-4b2d-9008-76a819cef7d7	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: FLUCONAZOLE generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fa2fa2f8-f3a6-4bc0-943c-03dabd0f1581	2023-04-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	A-S Medication Solutions	08a54805-4fdf-48fd-bc3e-e9fa38f3c691	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	b0aa9b22-5aef-459f-bb11-b193343eeb86	2023-02-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	88d9904c-0c21-4188-95e2-6479bdf359df	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Proficient Rx LP	fbb1bda3-f733-4404-9c9d-46c418700c03	2022-08-01	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
Fluconazole	FLUCONAZOLE	Asclemed USA, Inc.	56a9de97-bbb9-4210-9ace-f77317d5f33b	2022-03-04	Warnings, Adverse reactions	Name fallback brand name: Fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Proficient Rx LP	f232600e-70ce-4001-b9da-31442f0920b9	2020-03-01	Warnings, Adverse reactions	Name fallback brand name: fluconazole generic name: FLUCONAZOLE
fluconazole	FLUCONAZOLE	Proficient Rx LP	7c8bb5ff-37e7-4f5e-8ea7-12269b2c7fd3	2019-10-01	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