Application 205761

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	20MG	No	No

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
A205761-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205761-001	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 · 42 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	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 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	A205761-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205761-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205761-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205761-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205761-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205761-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205761-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205761-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205761-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205761-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205761-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205761-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205761-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205761-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205761-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205761-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205761-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205761-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205761-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205761-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205761-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205761-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205761-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205761-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205761-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205761-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205761-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205761-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205761-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205761-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205761-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205761-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205761-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205761-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205761-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205761-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205761-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205761-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205761-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205761-001	AB	1	`e64feba35796…`

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
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761 ndc (product): 72189-142
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761 ndc (product): 71335-1558
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Aurobindo Pharma Limited	d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761 ndc (product): 65862-721
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	12eaf996-db61-41d6-82e1-fa6196435603	2020-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761 ndc (product): 76420-107

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65862-721	Rabeprazole Sodium	Rabeprazole Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-721	Rabeprazole Sodium	Rabeprazole Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-721	Rabeprazole Sodium	Rabeprazole Sodium	Aurobindo Pharma Limited	ANDA	Current
65862-721	Rabeprazole Sodium	Rabeprazole Sodium	Aurobindo Pharma Limited	ANDA	Current
68788-7657	Rabeprazole Sodium	Rabeprazole Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7657	Rabeprazole Sodium	Rabeprazole Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7657	Rabeprazole Sodium	Rabeprazole Sodium	Preferred Pharmaceuticals, Inc.	ANDA	Current
70518-2860	Rabeprazole Sodium	Rabeprazole Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2860	Rabeprazole Sodium	Rabeprazole Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2860	Rabeprazole Sodium	Rabeprazole Sodium	REMEDYREPACK INC.	ANDA	Current
70518-2860	Rabeprazole Sodium	Rabeprazole Sodium	REMEDYREPACK INC.	ANDA	Current
71335-1558	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1558	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
71335-1558	Rabeprazole Sodium	Rabeprazole Sodium	Bryant Ranch Prepack	ANDA	Current
72189-142	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
72189-142	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
72189-142	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
72189-142	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
72189-142	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	ANDA	Current
76420-107	Rabeprazole Sodium	Rabeprazole Sodium	Asclemed USA, Inc.	ANDA	Current