Application 203062

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, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE	No	No
002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;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
A203062-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-07-01
A203062-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-07-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203062-001	AB
A203062-002	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	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203062-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203062-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2013-07-01	`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	A203062-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203062-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203062-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203062-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203062-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203062-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203062-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203062-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203062-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203062-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203062-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203062-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203062-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203062-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203062-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203062-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203062-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203062-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203062-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203062-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203062-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203062-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203062-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203062-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203062-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203062-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203062-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203062-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203062-002	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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Advanced Rx of Tennessee, LLC	4137a02e-dcec-c14c-e063-6294a90aa44f	2025-10-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	07605de4-bef2-70e8-e063-6394a90a33cc	2025-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	a8e37688-426c-4290-933d-54a34ae86000	2025-08-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 65862-626 ndc (product): 65862-625
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	REMEDYREPACK INC.	1e547fac-a9e5-4c7b-adba-4e6b75141183	2025-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Asclemed USA, Inc.	8fa794f4-4253-485d-b4ee-986178031339	2025-01-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate ODT	RIZATRIPTAN BENZOATE ODT	Direct Rx	db489d19-1509-c979-e053-2a95a90a4410	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 72189-341
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	74971372-75c6-4682-adbf-1c8e7b748fc1	2024-10-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 71335-1819
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	2337e102-8df0-4e7f-81d8-5cb86cd48674	2024-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 57237-085 ndc (product): 57237-086
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	NuCare Pharmaceuticals,Inc.	106dd370-c09c-556a-e063-6394a90acfed	2024-02-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	80c124ab-a083-4184-ba6b-199a7681b5d1	2023-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203062 application number: ANDA203062 ndc (product): 71205-557

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 25 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
55700-942	Rizatriptan Benzoate	Rizatriptan Benzoate	Quality Care Products, LLC	ANDA	Current
55700-958	Rizatriptan Benzoate	Rizatriptan Benzoate	Quality Care Products, LLC	ANDA	Current
57237-085	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-085	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-085	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-085	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-086	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-086	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-086	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
57237-086	Rizatriptan Benzoate	Rizatriptan Benzoate	Rising Health, LLC	ANDA	Current
65862-625	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-625	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-625	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-625	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-625	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-626	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-626	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-626	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-626	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
65862-626	Rizatriptan Benzoate	Rizatriptan Benzoate	Aurobindo Pharma Limited	ANDA	Current
68788-7497	Rizatriptan Benzoate	Rizatriptan Benzoate	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-557	Rizatriptan Benzoate	Rizatriptan Benzoate	Proficient Rx LP	ANDA	Current
71335-1819	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1819	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
72189-341	Rizatriptan Benzoate ODT	Rizatriptan Benzoate ODT	Direct Rx	ANDA	Current