Home Applications 020675 Application 020675
Type NDA
Sponsor ALLERGAN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 URSO 250 URSODIOL TABLET;ORAL 250MG Yes No 002 URSO FORTE URSODIOL TABLET;ORAL 500MG 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 N020675-001 URSO 250 URSODIOL 250MG TABLET / ORAL RLD 1997-12-10 N020675-002 URSO FORTE URSODIOL 500MG TABLET / ORAL RLD 2004-07-21
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 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020675-001 URSO 250 250MG TABLET / ORAL RLD 1997-12-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N020675-002 URSO FORTE 500MG TABLET / ORAL RLD 2004-07-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020675-001 URSO 250 250MG TABLET / ORAL AB RLD 1997-12-10 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N020675-002 URSO FORTE 500MG TABLET / ORAL AB RLD, RS 2004-07-21 bb7c543d1eb4…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 74 observed states.
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 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 16 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-2998 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2998 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2998 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3005 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3005 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-3005 Ursodiol Ursodiol Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 58914-785 Urso 250 Ursodiol Allergan, Inc. NDA Current 58914-785 Urso 250 Ursodiol Allergan, Inc. NDA Current 58914-785 Urso 250 Ursodiol Allergan, Inc. NDA Current 58914-785 Urso 250 Ursodiol Allergan, Inc. NDA Current 58914-785 Urso 250 Ursodiol Allergan, Inc. NDA Current 58914-790 Urso Forte Ursodiol Allergan, Inc. NDA Current 58914-790 Urso Forte Ursodiol Allergan, Inc. NDA Current 58914-790 Urso Forte Ursodiol Allergan, Inc. NDA Current 58914-790 Urso Forte Ursodiol Allergan, Inc. NDA Current 58914-790 Urso Forte Ursodiol Allergan, Inc. NDA Current