Application 019594

Type: NDA
Sponsor: ALLERGAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACTIGALL	URSODIOL	CAPSULE;ORAL	150MG	No	No
002	ACTIGALL	URSODIOL	CAPSULE;ORAL	300MG	Yes	Yes

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
N019594-001	ACTIGALL	URSODIOL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31
N019594-002	ACTIGALL	URSODIOL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019594-002	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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019594-001	ACTIGALL	150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CAPSULE / ORAL			1987-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019594-001	ACTIGALL	150MG	CAPSULE / ORAL			1987-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N019594-002	ACTIGALL	300MG	CAPSULE / ORAL	AB	RLD, RS	1987-12-31	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	N019594-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019594-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019594-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019594-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019594-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019594-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019594-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019594-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019594-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019594-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019594-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019594-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019594-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019594-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019594-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019594-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019594-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019594-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019594-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019594-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019594-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019594-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019594-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019594-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019594-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019594-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019594-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019594-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019594-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019594-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019594-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019594-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019594-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019594-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019594-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019594-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019594-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019594-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019594-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019594-002	AB	1	`e64feba35796…`

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	AvKARE	00c47258-aef0-53f6-e063-6294a90af96f	2026-01-19	Adverse reactions	Exact identifier application applno (NDA): 019594 application number: NDA019594
Ursodiol	URSODIOL	Actavis Pharma, Inc.	a061bb07-a85d-4b08-877f-ce02156f0de7	2025-08-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019594 application number: NDA019594 ndc (product): 0591-3159

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6145	Actigall	Ursodiol	Allergan, Inc.	NDA	Current
0023-6145	Actigall	Ursodiol	Allergan, Inc.	NDA	Current
0591-3159	Ursodiol	Ursodiol	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3159	Ursodiol	Ursodiol	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3159	Ursodiol	Ursodiol	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0591-3159	Ursodiol	Ursodiol	Actavis Pharma, Inc.	NDA AUTHORIZED GENERIC	Current
0615-1374	Ursodiol	Ursodiol	NCS HealthCare of KY, Inc dba Vangard Labs	NDA	Current
52544-930	Actigall	Ursodiol	Actavis Pharma, Inc.	NDA	Current
68151-2987	Ursodiol	Ursodiol	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current
68788-6807	Ursodiol	Ursodiol	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74841	SUPPL	2023-07-20
74802	SUPPL	2023-07-20
51025	SUPPL	2018-01-11
1405	SUPPL	2002-08-14