Application 090547

Type: ANDA
Sponsor: MYLAN PHARMS 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 42.

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
A090547-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2010-04-22
A090547-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2010-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090547-001	AB
A090547-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090547-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2010-04-22	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090547-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2010-04-22	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090547-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090547-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090547-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090547-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090547-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090547-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090547-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090547-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090547-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090547-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090547-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090547-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090547-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090547-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090547-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090547-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090547-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090547-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090547-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090547-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090547-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090547-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090547-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090547-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090547-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090547-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090547-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090547-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090547-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090547-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090547-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090547-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090547-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090547-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090547-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090547-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090547-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090547-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090547-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090547-002	AB	1	`bb7c543d1eb4…`

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	Safecor Health LLC	23f25c6b-f075-42dc-ae05-63b5bf410929	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090547 application number: ANDA090547
Voriconazole	VORICONAZOLE	Mylan Pharmaceuticals Inc.	67c174da-41b8-4738-8a22-dd814b8e96b8	2026-02-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090547 application number: ANDA090547 ndc (product): 0378-1626 ndc (product): 0378-1640
Voriconazole	VORICONAZOLE	Mylan Institutional Inc.	3af8cfe6-1c0d-4b57-ae31-05cffa64132e	2025-07-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090547 application number: ANDA090547 ndc (product): 51079-165 ndc (product): 51079-164

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1626	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-1640	Voriconazole	voriconazole	Mylan Pharmaceuticals Inc.	ANDA	Current
51079-164	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current
51079-164	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current
51079-164	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current
51079-165	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current
51079-165	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current
51079-165	Voriconazole	voriconazole	Mylan Institutional Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9275	ORIG	2010-04-28