Home Applications 021055 Application 021055
Type NDA
Sponsor VALEANT LUXEMBOURG Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 TARGRETIN BEXAROTENE CAPSULE;ORAL 75MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021055-001 TARGRETIN BEXAROTENE 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N021055-001 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.
Product history page 1 of 2 · 42 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 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021055-001 TARGRETIN 75MG CAPSULE / ORAL AB RLD, RS 1999-12-29 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 · 11 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0187-5526 Targretin bexarotene Bausch Health US LLC NDA Current 0187-5526 Targretin bexarotene Bausch Health US, LLC NDA Current 0187-5526 Targretin bexarotene Bausch Health US, LLC NDA Current 0187-5526 Targretin bexarotene Valeant Pharmaceuticals North America LLC NDA Current 0187-5526 Targretin bexarotene Bausch Health US, LLC NDA Current 0187-5526 Targretin bexarotene Bausch Health Americas, Inc. NDA Current 0187-5526 Targretin bexarotene Bausch Health US, LLC NDA Current 68682-003 bexarotene bexarotene Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-003 bexarotene bexarotene Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-003 bexarotene bexarotene Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current 68682-003 bexarotene bexarotene Oceanside Pharmaceuticals NDA AUTHORIZED GENERIC Current
Documents# Document, Submission type, Date table Document Submission type Date 14255 SUPPL 2015-08-04 26603 SUPPL 2015-07-30 14254 SUPPL 2014-03-26 26602 SUPPL 2012-01-09 4175 SUPPL 2011-05-19 35989 SUPPL 2011-05-18 26601 SUPPL 2003-05-29 4174 SUPPL 2003-05-29 35988 SUPPL 2003-04-28 14253 SUPPL 2003-04-28 41915 ORIG 2002-04-11 35987 ORIG 1999-12-29 4173 ORIG 1999-12-29