Application 210849

Type: ANDA
Sponsor: MYLAN LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VORICONAZOLE	VORICONAZOLE	INJECTABLE;INTRAVENOUS	200MG/VIAL	No	No

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

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A210849-001	VORICONAZOLE	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS			2022-10-11

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.

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	A210849-001	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS		2022-10-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210849-001	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS		2022-10-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210849-001	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS		2022-10-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210849-001	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS		2022-10-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS		2022-10-11	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210849-001	VORICONAZOLE	200MG/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-10-11	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210849-001	VORICONAZOLE	200MG/VIAL	POWDER / INTRAVENOUS		2022-10-11	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A210849-001	AP	1	`f41ea6bd6efb…`

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 2 of 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	Amneal Pharmaceuticals LLC	ed6624a9-0b73-4a21-bf13-a8add2081d02	2026-03-02	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Viona Pharmaceuticals Inc	75fcbea8-8eeb-4528-b7d9-a059dd25da83	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Zydus Lifesciences Limited	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	2026-02-26	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
VFEND	VORICONAZOLE	Roerig	ce3ef5cf-3087-4d92-9d94-9eb8287228db	2026-02-26	Warnings, Adverse reactions	Name fallback generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	67c174da-41b8-4738-8a22-dd814b8e96b8	2026-02-15	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	8217c621-976e-450b-8f48-5dc3119dc53c	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
VORICONAZOLE	VORICONAZOLE	Lupin Pharmaceuticals,Inc.	e37525e8-afb4-4583-b2de-af4aab9040d7	2025-09-26	Warnings, Adverse reactions	Name fallback brand name: VORICONAZOLE generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	American Health Packaging	8379ac92-53cd-46db-8642-017f11830a86	2025-09-18	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Slate Run Pharmaceuticals, LLC	2b262849-9a29-44a2-9b9d-2378f771379c	2025-09-09	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Camber Pharmaceuticals, Inc.	fceb92c5-5269-46e2-ac5f-547b2f77953d	2025-09-02	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Glenmark Pharmaceuticals Inc., USA	4cbac6ad-0faa-4181-a830-27a9f1536b7a	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Mylan Institutional Inc.	3af8cfe6-1c0d-4b57-ae31-05cffa64132e	2025-07-22	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	UBI Pharma Inc.	9a81e485-7f26-45b6-bfd7-6114afb7def9	2025-06-20	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	35098192-3bcb-9111-e063-6394a90ae8ea	2025-05-13	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	NorthStar Rx LLC	b38165a5-d8d4-4579-a49a-fbe92e764089	2025-05-02	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Zhejiang Poly Pharm Co., Ltd.	3266cf9b-e648-1ff2-e063-6394a90a0487	2025-04-10	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	AvPAK	e698e5c7-f4a5-2beb-e053-2995a90a256b	2025-01-09	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	711e5a1b-8c40-4b18-9f4f-12c8ab351012	2024-08-06	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Eugia US LLC	171272c7-d76e-4352-81bc-fcb40386d7d0	2024-03-05	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Fresenius Kabi USA, LLC	25eb8d91-5abd-4fdb-a331-dacc960a95d9	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.