Application 204090

Type: ANDA
Sponsor: EMCURE PHARMS 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 43.

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
A204090-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2013-11-26
A204090-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL			2013-11-26

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 · 86 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
2026-09-14 22:38:34	2026-08	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-11-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-11-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204090-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-11-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204090-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-11-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A204090-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204090-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A204090-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204090-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204090-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204090-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204090-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204090-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204090-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204090-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204090-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204090-002	AB	1	`ea99ee380514…`

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 3 · 43 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	REMEDYREPACK INC.	1e547fac-a9e5-4c7b-adba-4e6b75141183	2026-09-08	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan benzoate	RIZATRIPTAN BENZOATE	Chartwell RX, LLC	faf3bc1d-8818-47b0-8ad1-80bfbf40ab78	2026-09-01	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan benzoate generic name: RIZATRIPTAN BENZOATE
RIZAFILM	RIZATRIPTAN BENZOATE	A-S Medication Solutions	8e36b946-cf2a-44d9-9ba7-4385cfe6b360	2026-08-28	Warnings, Adverse reactions	Name fallback generic name: RIZATRIPTAN BENZOATE
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	673d584c-0691-d2fb-e053-2991aa0a7797	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Direct_Rx	f754388d-77f1-0d8d-e053-6394a90a7b7e	2026-03-17	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	direct rx	b3d981bc-3c9e-8a9e-e053-2995a90a8f65	2026-03-05	Warnings, Adverse reactions	Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	11a7f243-3a8b-41fd-a9fa-1dd2dcafab93	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
MAXALT	RIZATRIPTAN BENZOATE	Organon LLC	007b4644-e0e7-4863-9ae3-fe09676b3f5f	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	6391d2a1-252e-4e50-9d80-4dce12eabc8f	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	A-S Medication Solutions	187204ef-5370-476a-84b1-e3c54b60c6c2	2025-11-06	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Advanced Rx of Tennessee, LLC	4137a02e-dcec-c14c-e063-6294a90aa44f	2025-10-21	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Creekwood Pharmaceuticals LLC	b517896b-167e-47d5-801d-7458f80e8ee2	2025-10-09	Warnings, Adverse reactions	Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	07605de4-bef2-70e8-e063-6394a90a33cc	2025-08-20	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	a8e37688-426c-4290-933d-54a34ae86000	2025-08-06	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
RIZAFILM	RIZATRIPTAN BENZOATE	Gensco Laboratories LLC	fa32794e-d26d-e0bf-e053-6294a90abb0e	2025-04-27	Warnings, Adverse reactions	Name fallback generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	e7414f2d-d7cf-41e5-b457-f5850e8bb7a7	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Asclemed USA, Inc.	8fa794f4-4253-485d-b4ee-986178031339	2025-01-27	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Direct_Rx	05150193-cc2f-8b41-e063-6394a90a184c	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Direct Rx	d60560d5-8e52-099d-e053-2a95a90a20af	2025-01-21	Warnings, Adverse reactions	Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	2598cfb1-f875-43a5-aa10-246e026e9695	2024-12-10	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-244	Rizatriptan Benzoate	Rizatriptan Benzoate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-244	Rizatriptan Benzoate	Rizatriptan Benzoate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-245	Rizatriptan Benzoate	Rizatriptan Benzoate	Heritage Pharmaceuticals Inc.	ANDA	Current
23155-245	Rizatriptan Benzoate	Rizatriptan Benzoate	Heritage Pharmaceuticals Inc.	ANDA	Current