Application 205789

Type: ANDA
Sponsor: NEXGEN PHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	URSODIOL	URSODIOL	CAPSULE;ORAL	200MG	No	No
002	URSODIOL	URSODIOL	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205789-001	URSODIOL	URSODIOL	200MG	CAPSULE / ORAL			2020-05-08
A205789-002	URSODIOL	URSODIOL	400MG	CAPSULE / ORAL			2020-05-08

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 2 of 2 · 80 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A205789-002	URSODIOL	400MG	CAPSULE / ORAL		2020-05-08	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205789-002	URSODIOL	400MG	CAPSULE / ORAL	RS	2020-05-08	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205789-001	URSODIOL	200MG	CAPSULE / ORAL		2020-05-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A205789-002	URSODIOL	400MG	CAPSULE / ORAL		2020-05-08	`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
Ursodiol 200 mg	USODIOL	LGM PHARMA SOLUTIONS, LLC	ebaaa3e2-1d80-4b40-b696-88cdd06448e4	2024-11-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789 ndc (product): 79739-7144 ndc (product): 79739-7143
Ursodiol 200 mg	URSODIOL	FH2 Pharma LLC	476179dc-b410-4305-881b-470511765647	2023-12-31	Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789 ndc (product): 72887-143 ndc (product): 72887-144
Reltone 200 mg	URSODIOL	Intra-Sana Laboratories	d1c28b0b-8f3c-4d60-8182-24a4c659d762	2023-01-16	Adverse reactions	Exact identifier application applno (ANDA): 205789 application number: ANDA205789 ndc (product): 80056-144 ndc (product): 80056-143

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
0722-7143	Ursodiol 200 mg	Usodiol	Nexgen Pharma, Inc	ANDA	Current
0722-7144	Ursodiol 400 mg	Usodiol	Nexgen Pharma, Inc	ANDA	Current
72887-143	Ursodiol 200 mg	Ursodiol	FH2 Pharma LLC	ANDA	Current
72887-143	Ursodiol 200 mg	Ursodiol	FH2 Pharma LLC	ANDA	Current
72887-144	Ursodiol 400 mg	Ursodiol	FH2 Pharma LLC	ANDA	Current
72887-144	Ursodiol 400 mg	Ursodiol	FH2 Pharma LLC	ANDA	Current
79739-7143	Ursodiol 200 mg	Usodiol	LGM Pharma Solutions, LLC	ANDA	Current
79739-7144	Ursodiol 400 mg	Usodiol	LGM Pharma Solutions, LLC	ANDA	Current
80056-143	Reltone 200 mg	Ursodiol	Intra-Sana Laboratories	ANDA	Current
80056-144	Reltone 400 mg	Ursodiol	Intra-Sana Laboratories	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
63414	ORIG	2020-06-04