Application 091658

Type: ANDA
Sponsor: TEVA PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	VORICONAZOLE	VORICONAZOLE	TABLET;ORAL	50MG	No	No
002	VORICONAZOLE	VORICONAZOLE	TABLET;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A091658-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL			2012-04-06
A091658-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL			2012-04-06

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2012-04-06	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2012-04-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2012-04-06	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2012-04-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2012-04-06	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2012-04-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091658-001	VORICONAZOLE	50MG	TABLET / ORAL		2012-04-06	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A091658-002	VORICONAZOLE	200MG	TABLET / ORAL		2012-04-06	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A091658-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091658-002	AB	1	`74a2ff9319b5…`
2019-09-15 20:21 UTC	2019-09	A091658-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A091658-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A091658-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A091658-002	AB	1	`ea99ee380514…`

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	American Health Packaging	c620b2d7-3c2b-4252-8cfc-2f322d624435	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE INJECTION	PAI Holdings, LLC dba PAI Pharma	bceb01d5-c2d9-436d-896f-26643fa22d50	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Voriconazole
Voriconazole	VORICONAZOLE	Meitheal Pharmaceuticals Inc.	d962d459-254f-4b78-ae28-7d9ec5d4e4d5	2026-06-29	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	b8de04a0-238d-4e0b-b0d9-7f7878b149d4	2026-06-02	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Safecor Health LLC	23f25c6b-f075-42dc-ae05-63b5bf410929	2026-05-28	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Major Pharmaceuticals	796cad15-2aef-4823-917d-17b822a6916e	2026-05-27	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Slate Run Pharmaceuticals	7f2e0784-8e48-f565-e053-2991aa0a0746	2026-05-07	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Solco Healthcare U.S., LLC	f6a1a792-141b-42e8-8bd1-884e4408eb8a	2026-04-30	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Ajanta Pharma USA Inc.	16a80777-f1f3-45bb-a312-998b07767fe3	2026-04-24	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Camber Pharmaceuticals, Inc.	fff10d69-e334-42bd-baed-7d9d5feef6aa	2026-04-13	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Aurobindo Pharma Limited	4fe672ff-2cef-4f88-ab85-5a4b586da20d	2026-04-07	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Sandoz Inc	e648a0e4-f324-49dc-a8f6-cf25ff3b2dfe	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Civica, Inc.	511fa110-e4cc-4498-80db-03b7cddb1d5a	2026-03-31	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Sandoz Inc	e2b3c0b3-02a6-45c3-a8ea-05d210dc9108	2026-03-26	Warnings, Adverse reactions	Name fallback brand name: voriconazole generic name: VORICONAZOLE
VFEND	VORICONAZOLE	Roerig	08d08721-1f4c-478a-8abf-d9c402d50553	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: VORICONAZOLE
VFEND	VORICONAZOLE	Roerig	dac26bcd-7a59-401f-9f66-a0649767cece	2026-03-20	Warnings, Adverse reactions	Name fallback generic name: VORICONAZOLE
VORICONAZOLE	VORICONAZOLE	Hainan Poly Pharm. Co., Ltd.	393a81ba-7d51-450e-8d20-23287767c002	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: VORICONAZOLE generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Fosun Pharma USA Inc.	b3b67028-f8a0-4a93-9e73-9e8940c22c4a	2026-03-13	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
Voriconazole	VORICONAZOLE	Gland Pharma Limited	9d5b9457-ac38-4f17-854d-e394c00e273c	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: Voriconazole generic name: VORICONAZOLE
voriconazole	VORICONAZOLE	Major Pharmaceuticals	49dcf3ae-6d6b-46fe-a88e-ec65f2de332e	2026-03-05	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.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0093-5289	Voriconazole	Voriconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0093-5290	Voriconazole	Voriconazole	Teva Pharmaceuticals USA, Inc.	ANDA	Current
42291-900	Voriconazole	Voriconazole	AvKARE, Inc.	ANDA	Current