Application 208327

Type: ANDA
Sponsor: AMNEAL PHARMS

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
A208327-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-01-07
A208327-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2020-12-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208327-001	AB
A208327-002	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 · 76 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	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208327-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2020-12-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208327-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-01-07	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 76 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	A208327-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208327-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208327-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208327-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208327-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208327-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208327-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208327-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208327-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208327-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208327-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208327-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208327-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208327-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208327-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208327-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208327-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208327-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208327-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208327-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208327-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208327-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208327-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208327-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208327-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208327-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208327-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208327-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208327-001	AB	1	`782e0a99824c…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A208327-001	PC	2019-04-29	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A208327-001	PC	2019-04-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208327-001	PC	2019-04-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208327-001	PC	2019-04-29	`ea99ee380514…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABIRATERONE ACETATE	ABIRATERONE	AvKARE	c1200e4e-c4f7-9067-e053-2a95a90af509	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327 ndc (product): 42291-073
Abiraterone Acetate	ABIRATERONE	AvKARE	7f82d549-6654-1efd-e053-2991aa0aa28d	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327 ndc (product): 42291-024
Abiraterone Acetate	ABIRATERONE	American Health Packaging	b36bff33-595e-4827-9a73-85c6954c314c	2025-02-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
Abiraterone Acetate	ABIRATERONE	Amneal Pharmaceuticals NY LLC	6fda6b92-59ed-4180-af68-94052a5e82cf	2023-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327
Abiraterone Acetate	ABIRATERONE	Amneal Pharmaceuticals NY LLC	c9eb9b46-f847-40a8-802c-a51b40406d5a	2023-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208327 application number: ANDA208327 ndc (product): 69238-1754 ndc (product): 69238-1165

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-024	Abiraterone Acetate	Abiraterone	AvKARE, Inc.	ANDA	Current
42291-024	Abiraterone Acetate	Abiraterone	AvKARE	ANDA	Current
42291-024	Abiraterone Acetate	Abiraterone	AvKARE	ANDA	Current
42291-073	ABIRATERONE ACETATE	ABIRATERONE	AvKARE	ANDA	Current
42291-073	ABIRATERONE ACETATE	ABIRATERONE	AvKARE	ANDA	Current
60687-455	Abiraterone Acetate	Abiraterone	American Health Packaging	ANDA	Current
60687-455	Abiraterone Acetate	Abiraterone	American Health Packaging	ANDA	Current
60687-455	Abiraterone Acetate	Abiraterone	American Health Packaging	ANDA	Current
60687-455	Abiraterone Acetate	Abiraterone	American Health Packaging	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1165	Abiraterone Acetate	Abiraterone	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1754	ABIRATERONE ACETATE	ABIRATERONE	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1754	ABIRATERONE ACETATE	ABIRATERONE	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1754	ABIRATERONE ACETATE	ABIRATERONE	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1754	ABIRATERONE ACETATE	ABIRATERONE	Amneal Pharmaceuticals NY LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50336	ORIG	2017-11-08