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#

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	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