Application 210686

Type: ANDA
Sponsor: MSN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	TABLET;ORAL	250MG	No	No
002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	TABLET;ORAL	500MG	No	No

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
A210686-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-07-10
A210686-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2024-04-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A210686-001	AB
A210686-002	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 · 58 observed 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	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210686-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2024-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210686-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-07-10	`c0c555d07b60…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A210686-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210686-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210686-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210686-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210686-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210686-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210686-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210686-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210686-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210686-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210686-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210686-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210686-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210686-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210686-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210686-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210686-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210686-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210686-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210686-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210686-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210686-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210686-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210686-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210686-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210686-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210686-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210686-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210686-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210686-001	AB	1	`c0c555d07b60…`

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
Abiraterone	ABIRATERONE ACETATE	BluePoint Laboratories	32f6b83d-c743-4934-9a20-1b5bf9f4eea3	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686 ndc (product): 68001-489
Abiraterone	ABIRATERONE ACETATE	Novadoz Pharmaceuticals LLC	88d05db3-8bdc-47f1-bb00-6b4a71f98609	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686 ndc (product): 72205-030
Abiraterone	ABIRATERONE ACETATE	Quallent Pharmaceuticals Health LLC	6f5b628b-69da-4a04-a4d5-623b18d1fd5d	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210686 application number: ANDA210686

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
68001-489	Abiraterone	Abiraterone acetate	BluePoint Laboratories	ANDA	Current
68001-489	Abiraterone	Abiraterone acetate	BluePoint Laboratories	ANDA	Current
68001-489	Abiraterone	Abiraterone acetate	BluePoint Laboratories	ANDA	Current
68001-489	Abiraterone	Abiraterone acetate	BluePoint Laboratories	ANDA	Current
69539-049	Abiraterone	Abiraterone acetate	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-049	Abiraterone	Abiraterone acetate	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-049	Abiraterone	Abiraterone acetate	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
69539-049	Abiraterone	Abiraterone acetate	MSN LABORATORIES PRIVATE LIMITED	ANDA	Current
72205-030	Abiraterone	Abiraterone acetate	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-030	Abiraterone	Abiraterone acetate	Novadoz Pharmaceuticals LLC	ANDA	Current
72205-030	Abiraterone	Abiraterone acetate	Novadoz Pharmaceuticals LLC	ANDA	Current