Application 203503

Type: ANDA
Sponsor: GLENMARK PHARMS LTD

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
A203503-001	VORICONAZOLE	VORICONAZOLE	50MG	TABLET / ORAL	AB		2015-09-02
A203503-002	VORICONAZOLE	VORICONAZOLE	200MG	TABLET / ORAL	AB		2015-09-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203503-001	AB
A203503-002	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	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203503-001	VORICONAZOLE	50MG	TABLET / ORAL	AB	2015-09-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203503-002	VORICONAZOLE	200MG	TABLET / ORAL	AB	2015-09-02	`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	A203503-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203503-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203503-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203503-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203503-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203503-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203503-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203503-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203503-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203503-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203503-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203503-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203503-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203503-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203503-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203503-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203503-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203503-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203503-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203503-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203503-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203503-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203503-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203503-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203503-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203503-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203503-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203503-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203503-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Voriconazole	VORICONAZOLE	American Health Packaging	8379ac92-53cd-46db-8642-017f11830a86	2025-09-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203503 application number: ANDA203503 ndc (product): 60687-273 ndc (product): 60687-294
voriconazole	VORICONAZOLE	Glenmark Pharmaceuticals Inc., USA	4cbac6ad-0faa-4181-a830-27a9f1536b7a	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203503 application number: ANDA203503 ndc (product): 68462-572 ndc (product): 68462-573

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-133	voriconazole	voriconazole	Golden State Medical Supply Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
51407-133	voriconazole	voriconazole	Golden State Medical Supply, Inc.	ANDA	Current
60687-273	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-273	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-273	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-273	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-294	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-294	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-294	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
60687-294	Voriconazole	Voriconazole	American Health Packaging	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-572	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-573	voriconazole	voriconazole	Glenmark Pharmaceuticals Inc., USA	ANDA	Current