Application 209227

Type: ANDA
Sponsor: GLENMARK 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 1.

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
A209227-001	ABIRATERONE ACETATE	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB		2019-10-16
A209227-002	ABIRATERONE ACETATE	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB		2022-05-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209227-001	AB
A209227-002	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 · 68 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	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209227-002	ABIRATERONE ACETATE	500MG	TABLET / ORAL	AB	2022-05-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209227-001	ABIRATERONE ACETATE	250MG	TABLET / ORAL	AB	2019-10-16	`3f01610625f2…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 68 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	A209227-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209227-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209227-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209227-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209227-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209227-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209227-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209227-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209227-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209227-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209227-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209227-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209227-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209227-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209227-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209227-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209227-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209227-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209227-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209227-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209227-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209227-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209227-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209227-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209227-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209227-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209227-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209227-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209227-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209227-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209227-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209227-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209227-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209227-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209227-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209227-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209227-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209227-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209227-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209227-001	AB	1	`3f01610625f2…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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	NORTHSTAR RX LLC	42d5baa8-aca7-49d8-9c24-9d87b707ec20	2026-05-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209227 application number: ANDA209227 ndc (product): 72603-111 ndc (product): 72603-110
abiraterone acetate	ABIRATERONE ACETATE	Glenmark Pharmaceuticals Inc., USA	ba32c453-a231-452a-a6d9-b3e57afb2e75	2026-01-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209227 application number: ANDA209227 ndc (product): 68462-135 ndc (product): 68462-882

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
68462-135	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-135	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-135	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-135	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-135	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-882	abiraterone acetate	abiraterone acetate	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
72603-110	abiraterone acetate	abiraterone acetate	NORTHSTAR RX LLC	ANDA	Current
72603-110	abiraterone acetate	abiraterone acetate	NORTHSTAR RX LLC	ANDA	Current
72603-111	abiraterone acetate	abiraterone acetate	NORTHSTAR RX LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57749	ORIG	2019-02-21