Application 208380

Type: ANDA
Sponsor: WOCKHARDT BIO AG

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
A208380-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208380-001	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	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208380-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-02-27	`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	A208380-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208380-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208380-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208380-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208380-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208380-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208380-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208380-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208380-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208380-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208380-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208380-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208380-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208380-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208380-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208380-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208380-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208380-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208380-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208380-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208380-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208380-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208380-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208380-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208380-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208380-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208380-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208380-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208380-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208380-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208380-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208380-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208380-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208380-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208380-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208380-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208380-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208380-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208380-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A208380-001	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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ABIRATERONE ACETATE	ABIRATERONE ACETATE	Golden State Medical Supply, Inc.	445e70a1-25bd-8fc1-e063-6394a90a1a43	2026-06-16	Warnings, Adverse reactions	Name fallback brand name: ABIRATERONE ACETATE generic name: ABIRATERONE ACETATE
YONSA	ABIRATERONE ACETATE	Sun Pharmaceutical Industries, Inc.	b8967e10-f768-47ce-ac9e-2324c8390132	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
abiraterone acetate	ABIRATERONE ACETATE	NORTHSTAR RX LLC	42d5baa8-aca7-49d8-9c24-9d87b707ec20	2026-05-05	Warnings, Adverse reactions	Name fallback brand name: abiraterone acetate generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE ACETATE	AvPAK	5108c2fe-9706-c976-e063-6294a90a796d	2026-05-04	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE ACETATE	Mylan Pharmaceuticals Inc.	fe02db79-fa04-441f-b514-70bd74af6624	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
Abiraterone	ABIRATERONE ACETATE	BluePoint Laboratories	32f6b83d-c743-4934-9a20-1b5bf9f4eea3	2026-03-24	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE ACETATE	Major Pharmaceuticals	49809a29-6558-43a3-a347-5027de44aa41	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
abiraterone acetate	ABIRATERONE ACETATE	Glenmark Pharmaceuticals Inc., USA	ba32c453-a231-452a-a6d9-b3e57afb2e75	2026-01-30	Warnings, Adverse reactions	Name fallback brand name: abiraterone acetate generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE	AvKARE	7f82d549-6654-1efd-e053-2991aa0aa28d	2026-01-13	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate
Abiraterone Acetate	ABIRATERONE ACETATE	Novugen Pharma (USA) LLC	f308b463-27e4-422a-95a2-ecbbf95eee20	2026-01-07	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
Abiraterone	ABIRATERONE ACETATE	Novadoz Pharmaceuticals LLC	88d05db3-8bdc-47f1-bb00-6b4a71f98609	2025-11-12	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone	ABIRATERONE ACETATE	CivicaScript, LLC	0ef857ee-2bfc-4d27-a417-ad58fc3a6ff6	2025-10-21	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone	ABIRATERONE ACETATE	PD-Rx Pharmaceuticals, Inc.	413c645e-074d-4276-b39a-d83521077602	2025-10-08	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE ACETATE	Apotex Corp.	2ac063f0-4177-c90f-27c3-e70e29689255	2025-09-16	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
Zytiga	ABIRATERONE ACETATE	Janssen Biotech, Inc.	4e338e89-3cf2-48eb-b6e2-a06c608c6513	2025-03-28	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE ACETATE	Dr. Reddys Laboratories Inc	0c91aa38-3b0a-232c-8eb1-55f08e8e6644	2025-03-17	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate generic name: ABIRATERONE ACETATE
Abirtega	ABIRATERONE ACETATE	CivicaScript, LLC	2f932015-28b2-4f44-ac04-772e982e13e9	2025-02-28	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE
Abiraterone Acetate	ABIRATERONE	American Health Packaging	b36bff33-595e-4827-9a73-85c6954c314c	2025-02-26	Warnings, Adverse reactions	Name fallback brand name: Abiraterone Acetate
Abiraterone acetate	ABIRATERONE ACETATE	Florida Pharmaceutical Products, LLC	68121a71-5024-4f9e-bd9c-2d412f6a6355	2025-01-12	Warnings, Adverse reactions	Name fallback brand name: Abiraterone acetate generic name: ABIRATERONE ACETATE
Abiraterone	ABIRATERONE ACETATE	Hikma Pharmaceuticals USA Inc.	be29365a-ed25-44c0-9818-e9016dc95ba6	2024-12-20	Warnings, Adverse reactions	Name fallback generic name: ABIRATERONE ACETATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64679-021	Abiraterone acetate	Abiraterone acetate	Wockhardt USA LLC.	ANDA	Current
64679-021	Abiraterone acetate	Abiraterone acetate	Wockhardt USA LLC.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
50358	ORIG	2017-11-09