Application 203663

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	BEXAROTENE	BEXAROTENE	CAPSULE;ORAL	75MG	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
A203663-001	BEXAROTENE	BEXAROTENE	75MG	CAPSULE / ORAL	AB		2020-06-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203663-001	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	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203663-001	BEXAROTENE	75MG	CAPSULE / ORAL	AB	2020-06-16	`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	A203663-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203663-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203663-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203663-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203663-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203663-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203663-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203663-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203663-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203663-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203663-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203663-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203663-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203663-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203663-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203663-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203663-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203663-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A203663-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203663-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A203663-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A203663-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A203663-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A203663-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A203663-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A203663-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A203663-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A203663-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A203663-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A203663-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A203663-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A203663-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A203663-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A203663-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A203663-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A203663-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A203663-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A203663-001	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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bexarotene	BEXAROTENE	AvKARE	f9514265-6e2c-9030-e053-6394a90aa04b	2025-10-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
Bexarotene	BEXAROTENE	ANI Pharmaceuticals, Inc.	e713c60d-f623-4260-b0ca-db07e1365fd2	2025-09-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
Bexarotene	BEXAROTENE	Camber Pharmaceuticals, Inc.	374c42b1-3d7f-4ca3-9d3a-2a111286f7ca	2025-01-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
bexarotene	BEXAROTENE	Actavis Pharma, Inc.	3292c63c-052f-4f28-b739-530a86e660bf	2024-02-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: bexarotene generic name: BEXAROTENE
Bexarotene	BEXAROTENE	Amneal Pharmaceuticals NY LLC	2c21f361-e3d1-45a5-a6e7-df8164e3f90d	2023-12-29	Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
Bexarotene	BEXAROTENE	Upsher-Smith Laboratories, Inc.	7437a43f-172a-4f4e-8132-fe23b00224f9	2023-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
Bexarotene	BEXAROTENE	Amneal Pharmaceuticals NY LLC	d7fc7c7b-2ecf-4543-8bb4-9b4415d66613	2022-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE
Targretin	BEXAROTENE	Bausch Health US, LLC	1d056725-0576-4338-8089-6336e768ccdc	2020-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: BEXAROTENE
Targretin	BEXAROTENE	Bausch Health US, LLC	d35b4697-3f3b-4aa1-b5d9-153993e83811	2020-02-03	Adverse reactions	Name fallback generic name: BEXAROTENE
Bexarotene	BEXAROTENE	Mylan Pharmaceuticals Inc.	2d1eb4bd-51f9-4c9b-9fb1-0be5e30a3dc5	2018-06-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Bexarotene generic name: BEXAROTENE

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
0054-0399	Bexarotene	bexarotene	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0399	Bexarotene	bexarotene	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0054-0399	Bexarotene	bexarotene	Hikma Pharmaceuticals USA Inc.	ANDA	Current