Application 206747

Type: ANDA
Sponsor: CADILA

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 1.

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
A206747-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-05-24
A206747-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2016-05-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A206747-001	AB
A206747-002	AB

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 3 · 82 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
2026-02-19 14:30 UTC	2026-02	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206747-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-05-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206747-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-05-24	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A206747-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206747-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206747-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206747-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206747-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206747-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206747-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206747-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206747-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206747-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206747-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206747-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206747-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206747-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206747-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206747-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206747-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206747-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206747-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206747-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206747-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206747-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206747-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206747-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206747-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206747-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206747-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206747-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206747-002	AB	1	`782e0a99824c…`

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 1 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
voriconazole	VORICONAZOLE	Major Pharmaceuticals	49dcf3ae-6d6b-46fe-a88e-ec65f2de332e	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747 ndc (product): 0904-6596
voriconazole	VORICONAZOLE	Viona Pharmaceuticals Inc	75fcbea8-8eeb-4528-b7d9-a059dd25da83	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747 ndc (product): 72578-063 ndc (product): 72578-062
voriconazole	VORICONAZOLE	Zydus Lifesciences Limited	bda70104-d84b-4d3f-9ca0-5f4f1ca816ad	2026-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206747 application number: ANDA206747 ndc (product): 65841-830 ndc (product): 65841-831

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 45 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6596	voriconazole	voriconazole	Major Pharmaceuticals	ANDA	Current
0904-6596	voriconazole	voriconazole	Major Pharmaceuticals	ANDA	Current
0904-6596	voriconazole	voriconazole	Major Pharmaceuticals	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Zydus Lifesciences Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-830	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Zydus Lifesciences Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
65841-831	voriconazole	voriconazole	Cadila Healthcare Limited	ANDA	Current
68382-735	voriconazole	voriconazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-735	voriconazole	voriconazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-736	voriconazole	voriconazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-736	voriconazole	voriconazole	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-062	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current
72578-063	voriconazole	voriconazole	Viona Pharmaceuticals Inc	ANDA	Current