Application 208339

Type: ANDA
Sponsor: HIKMA 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
A208339-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2018-10-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208339-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208339-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2018-10-31	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A208339-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208339-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208339-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208339-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208339-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208339-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208339-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208339-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208339-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208339-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208339-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208339-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208339-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208339-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208339-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208339-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208339-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208339-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208339-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208339-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208339-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208339-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208339-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208339-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208339-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208339-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208339-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208339-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208339-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208339-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208339-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208339-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208339-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208339-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208339-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208339-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208339-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208339-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208339-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208339-001	AB	1	`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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abiraterone	ABIRATERONE ACETATE	CivicaScript, LLC	0ef857ee-2bfc-4d27-a417-ad58fc3a6ff6	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208339 application number: ANDA208339 ndc (product): 82249-010
Abiraterone	ABIRATERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	413c645e-074d-4276-b39a-d83521077602	2025-10-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208339 application number: ANDA208339 ndc (product): 72789-213
Abirtega	ABIRATERONE ACETATE	CivicaScript, LLC	2f932015-28b2-4f44-ac04-772e982e13e9	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208339 application number: ANDA208339
Abiraterone	ABIRATERONE ACETATE	Hikma Pharmaceuticals USA Inc.	be29365a-ed25-44c0-9818-e9016dc95ba6	2024-12-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208339 application number: ANDA208339 ndc (product): 0143-9597

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9597	Abiraterone	Abiraterone acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9597	Abiraterone	Abiraterone acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9597	Abiraterone	Abiraterone acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9597	Abiraterone	Abiraterone acetate	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9597	Abiraterone	Abiraterone acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9597	Abiraterone	Abiraterone acetate	Hikma Pharmaceuticals USA Inc.	ANDA	Current
72789-213	Abiraterone	Abiraterone acetate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-213	Abiraterone	Abiraterone acetate	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
82249-010	Abiraterone	Abiraterone acetate	CivicaScript, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
56278	ORIG	2018-11-05