Home Applications 215398 Application 215398
Type ANDA
Sponsor AMNEAL PHARMS LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 BEXAROTENE BEXAROTENE GEL;TOPICAL 1% No No
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 A215398-001 BEXAROTENE BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215398-001 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 RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215398-001 BEXAROTENE 1% GEL / TOPICAL AB 2022-04-27 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215398-001 CGT 2022-11-13 5c6f7cd8ea54…2023-01-26 05:58 UTC 2023-01 A215398-001 CGT 2022-11-13 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215398-001 CGT 2022-11-13 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215398-001 CGT 2022-11-13 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215398-001 CGT 2022-11-13 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215398-001 CGT 2022-11-13 cb3db0bc1861…
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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 69238-2088 Bexarotene Bexarotene Amneal Pharmaceuticals NY LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 71936 ORIG 2022-08-26