Application 200265

Type: ANDA
Sponsor: SANDOZ INC

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
A200265-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2011-12-12
A200265-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2011-12-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200265-001	AB
A200265-002	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	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200265-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2011-12-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200265-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2011-12-12	`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	A200265-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200265-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200265-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200265-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200265-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200265-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200265-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200265-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200265-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200265-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200265-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200265-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200265-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200265-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200265-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200265-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200265-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200265-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200265-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200265-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200265-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200265-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200265-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200265-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200265-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200265-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200265-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200265-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200265-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200265-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200265-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200265-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200265-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200265-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200265-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200265-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200265-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200265-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200265-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200265-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
voriconazole	VORICONAZOLE	Sandoz Inc	e2b3c0b3-02a6-45c3-a8ea-05d210dc9108	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200265 application number: ANDA200265 ndc (product): 0781-5667 ndc (product): 0781-5668
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	8217c621-976e-450b-8f48-5dc3119dc53c	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200265 application number: ANDA200265
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	35098192-3bcb-9111-e063-6394a90ae8ea	2025-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200265 application number: ANDA200265
voriconazole	VORICONAZOLE	Bryant Ranch Prepack	711e5a1b-8c40-4b18-9f4f-12c8ab351012	2024-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200265 application number: ANDA200265 ndc (product): 63629-8734

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 23 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5667	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0781-5668	voriconazole	voriconazole	Sandoz Inc	ANDA	Current
0904-6471	voriconazole	voriconazole	Major Pharmaceuticals	ANDA	Current
0904-6471	voriconazole	voriconazole	Major Pharmaceuticals	ANDA	Current
63629-8734	voriconazole	voriconazole	Bryant Ranch Prepack	ANDA	Current
63629-8734	voriconazole	voriconazole	Bryant Ranch Prepack	ANDA	Current
63629-8734	voriconazole	voriconazole	Bryant Ranch Prepack	ANDA	Current
63739-707	voriconazole	voriconazole	McKesson Corporation dba SKY Packaging	ANDA	Current
63739-707	voriconazole	voriconazole	McKesson Corporation dba SKY Packaging	ANDA	Current