Application 208416

Type: ANDA
Sponsor: DR REDDYS LABS LTD

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
A208416-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2020-05-18
A208416-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2023-09-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208416-001	AB
A208416-002	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 · 59 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	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208416-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2023-09-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208416-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2020-05-18	`6a51e52b5d6a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 59 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	A208416-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208416-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208416-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208416-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208416-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208416-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208416-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208416-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208416-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208416-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208416-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208416-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208416-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208416-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208416-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208416-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208416-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208416-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208416-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208416-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208416-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208416-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208416-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A208416-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208416-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208416-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208416-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208416-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208416-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208416-001	AB	1	`6a51e52b5d6a…`

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 Acetate	ABIRATERONE ACETATE	AvPAK	5108c2fe-9706-c976-e063-6294a90a796d	2026-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416
Abiraterone Acetate	ABIRATERONE ACETATE	Dr. Reddys Laboratories Inc	0c91aa38-3b0a-232c-8eb1-55f08e8e6644	2025-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416
Abiraterone Acetate	ABIRATERONE ACETATE	NorthStar Rx LLC	39434b24-bf64-f5c9-fbb6-b0d225099424	2023-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416 ndc (product): 16714-963
Abiraterone Acetate	ABIRATERONE ACETATE	Dr. Reddys Laboratories Inc	7eda0d98-c2ba-c117-b757-1f566292e789	2023-09-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208416 application number: ANDA208416 ndc (product): 43598-358

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-963	Abiraterone Acetate	Abiraterone Acetate	NorthStar Rx LLC	ANDA	Current
16714-963	Abiraterone Acetate	Abiraterone Acetate	NorthStar Rx LLC	ANDA	Current
16714-963	Abiraterone Acetate	Abiraterone Acetate	NorthStar Rx LLC	ANDA	Current
43598-358	Abiraterone Acetate	Abiraterone Acetate	Dr. Reddys Laboratories Inc	ANDA	Current
43598-358	Abiraterone Acetate	Abiraterone Acetate	Dr. Reddys Laboratories Inc	ANDA	Current
43598-358	Abiraterone Acetate	Abiraterone Acetate	Dr. Reddys Laboratories Inc	ANDA	Current
43598-358	Abiraterone Acetate	Abiraterone Acetate	Dr. Reddys Laboratories Inc	ANDA	Current
43598-358	Abiraterone Acetate	Abiraterone Acetate	Dr. Reddys Laboratories Inc	ANDA	Current