Application 206654

Type: ANDA
Sponsor: PRINSTON 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
A206654-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2016-08-08
A206654-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2016-08-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206654-001	AB
A206654-002	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	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206654-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2016-08-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206654-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2016-08-08	`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	A206654-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206654-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206654-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206654-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206654-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206654-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206654-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206654-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206654-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206654-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206654-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206654-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206654-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206654-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206654-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206654-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206654-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206654-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206654-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A206654-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206654-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206654-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206654-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206654-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206654-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206654-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206654-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A206654-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206654-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206654-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206654-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A206654-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206654-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A206654-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206654-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A206654-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206654-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A206654-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206654-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A206654-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	Solco Healthcare U.S., LLC	f6a1a792-141b-42e8-8bd1-884e4408eb8a	2026-04-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206654 application number: ANDA206654 ndc (product): 43547-378 ndc (product): 43547-377
Voriconazole	VORICONAZOLE	AvPAK	e698e5c7-f4a5-2beb-e053-2995a90a256b	2025-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206654 application number: ANDA206654 ndc (product): 50268-803

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43547-377	Voriconazole	Voriconazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-377	Voriconazole	Voriconazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-378	Voriconazole	Voriconazole	Solco Healthcare U.S., LLC	ANDA	Current
43547-378	Voriconazole	Voriconazole	Solco Healthcare U.S., LLC	ANDA	Current
50268-803	Voriconazole	Voriconazole	AvPAK	ANDA	Current