Application 210344

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URSODIOL	URSODIOL	CAPSULE;ORAL	300MG	No	No
002	URSODIOL	URSODIOL	CAPSULE;ORAL	150MG	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
A210344-001	URSODIOL	URSODIOL	300MG	CAPSULE / ORAL	AB		2021-01-22
A210344-002	URSODIOL	URSODIOL	150MG	CAPSULE / ORAL			2026-01-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210344-001	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.

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	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210344-001	URSODIOL	300MG	CAPSULE / ORAL	AB	2021-01-22	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210344-002	URSODIOL	150MG	CAPSULE / ORAL		2026-01-16	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210344-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210344-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210344-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210344-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210344-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210344-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210344-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210344-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210344-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210344-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210344-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210344-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210344-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210344-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210344-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210344-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210344-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210344-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A210344-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210344-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210344-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210344-001	AB	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210344-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210344-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210344-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210344-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210344-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210344-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210344-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210344-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210344-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210344-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210344-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A210344-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A210344-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A210344-001	AB	1	`a50c72e98297…`

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
URSOLIGN	URSODIOL	Pangea Pharmaceuticals, LLC	3617fb7a-1f57-4276-bebb-ae6ba4252d4e	2026-06-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344
URSODIOL	URSODIOL	Golden State Medical Supply, Inc.	fb317988-a4e3-9c9a-e053-6294a90a5990	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344
URSODIOL	URSODIOL	Strides Pharma Science Limited	9a6c1928-2d52-4d9a-8e83-f71892a7e98d	2026-03-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210344 application number: ANDA210344 ndc (product): 64380-844

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-844	URSODIOL	ursodiol	Strides Pharma Science Limited	ANDA	Current
64380-844	URSODIOL	ursodiol	Strides Pharma Science Limited	ANDA	Current
64380-844	URSODIOL	ursodiol	Strides Pharma Science Limited	ANDA	Current