Application 210308

Type: NDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	YONSA	ABIRATERONE ACETATE	TABLET;ORAL	125MG	Yes	Yes

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
N210308-001	YONSA	ABIRATERONE ACETATE	125MG	TABLET / ORAL		RLD, RS	2018-05-22

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210308-001	9889144	2034-03-17		Drug product	2018-07-19
N210308-001	10292990	2034-05-20	U-2535		2019-05-31

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N210308-001	YONSA	125MG	TABLET / ORAL		RLD, RS	2018-05-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210308-001	YONSA	125MG	TABLET / ORAL	AB	RLD, RS	2018-05-22	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N210308-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N210308-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N210308-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N210308-001	AB	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N210308-001	9889144	2034-03-17		Drug product	2018-07-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210308-001	10292990	2034-05-20	U-2535		2019-05-31	`bb7c543d1eb4…`

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 · 2 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	Exact identifier application applno (NDA): 210308 application number: NDA210308
YONSA	ABIRATERONE ACETATE	Sun Pharmaceutical Industries, Inc.	b8967e10-f768-47ce-ac9e-2324c8390132	2026-06-08	Warnings, Adverse reactions	Exact identifier application applno (NDA): 210308 application number: NDA210308 ndc (product): 47335-401

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
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current
47335-401	YONSA	abiraterone acetate	Sun Pharmaceutical Industries, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85937	SUPPL	2026-05-18
85917	SUPPL	2026-05-15
70607	SUPPL	2022-03-25
70601	SUPPL	2022-03-25
70040	SUPPL	2022-02-01
70021	SUPPL	2022-02-01
64614	SUPPL	2020-09-18
64600	SUPPL	2020-09-18
55868	ORIG	2018-10-11
54328	ORIG	2018-05-24
54311	ORIG	2018-05-23