Application 090801

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URSODIOL	URSODIOL	TABLET;ORAL	250MG	No	No
002	URSODIOL	URSODIOL	TABLET;ORAL	500MG	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
A090801-001	URSODIOL	URSODIOL	250MG	TABLET / ORAL	AB		2011-07-12
A090801-002	URSODIOL	URSODIOL	500MG	TABLET / ORAL	AB		2011-07-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090801-001	AB
A090801-002	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	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090801-001	URSODIOL	250MG	TABLET / ORAL	AB	2011-07-12	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090801-002	URSODIOL	500MG	TABLET / ORAL	AB	2011-07-12	`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	A090801-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090801-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090801-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090801-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090801-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090801-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090801-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090801-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090801-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090801-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090801-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090801-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090801-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090801-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090801-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090801-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090801-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090801-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090801-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090801-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090801-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090801-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090801-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090801-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090801-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090801-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090801-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090801-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090801-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090801-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090801-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090801-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090801-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090801-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090801-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090801-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090801-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090801-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090801-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090801-002	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
Ursodiol	URSODIOL	BluePoint Laboratories	a3c98080-0a4d-4a93-8dcb-02ab8533050b	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090801 application number: ANDA090801 ndc (product): 68001-378 ndc (product): 68001-377
Ursodiol	URSODIOL	Glenmark Pharmaceuticals Inc., USA	fb79b62a-b450-4d7a-be28-5ee4d174fd58	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090801 application number: ANDA090801 ndc (product): 68462-473 ndc (product): 68462-474

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
68001-377	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-377	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-378	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68001-378	Ursodiol	Ursodiol	BluePoint Laboratories	ANDA	Current
68462-473	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-473	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-473	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-473	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-473	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-474	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-474	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-474	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-474	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-474	Ursodiol	Ursodiol	Glenmark Pharmaceuticals Inc., USA	ANDA	Current