Application 202490

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET;ORAL	EQ 10MG BASE	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
A202490-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB		2012-12-31
A202490-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB		2012-12-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202490-001	AB
A202490-002	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 3 · 82 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	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202490-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202490-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202490-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202490-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202490-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202490-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202490-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202490-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202490-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202490-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202490-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202490-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202490-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202490-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202490-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202490-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202490-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202490-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202490-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202490-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202490-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202490-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202490-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202490-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202490-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202490-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202490-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202490-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202490-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202490-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202490-002	AB	1	`782e0a99824c…`

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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	673d584c-0691-d2fb-e053-2991aa0a7797	2026-03-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 61919-656
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	direct rx	b3d981bc-3c9e-8a9e-e053-2995a90a8f65	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 72189-258
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	A-S Medication Solutions	187204ef-5370-476a-84b1-e3c54b60c6c2	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 50090-3367
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	e7414f2d-d7cf-41e5-b457-f5850e8bb7a7	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Direct_Rx	05150193-cc2f-8b41-e063-6394a90a184c	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	2598cfb1-f875-43a5-aa10-246e026e9695	2024-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	03b5a887-d689-48a6-bd41-ae1ab4ae4990	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 71335-1912
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	01762e5f-db9a-49b3-8da1-60967970a318	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 71335-1149
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	075f47ee-88d1-102b-e063-6394a90acbf8	2024-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	222f77ff-d3f7-40f9-989c-e5902f44ef1e	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 57237-088 ndc (product): 57237-087
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 65862-599 ndc (product): 65862-600
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	4a5b43f6-a5ea-4d6f-941f-3c19f242c896	2022-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202490 application number: ANDA202490 ndc (product): 71205-644

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3367	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
50090-3367	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
50090-3367	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
57237-087	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-087	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-087	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-087	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-087	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-088	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-088	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-088	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-088	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-088	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
61919-656	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	ANDA	Current
65862-599	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-599	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-599	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-599	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-599	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-600	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-600	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-600	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-600	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-600	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
71205-644	Rizatriptan Benzoate	Rizatriptan Benzoate	Proficient Rx LP	ANDA	Current
71205-644	Rizatriptan Benzoate	Rizatriptan Benzoate	Proficient Rx LP	ANDA	Current
71335-1149	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1149	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1912	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1912	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
72189-258	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	direct rx	ANDA	Current
72189-258	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	direct rx	ANDA	Current