Application 200482

Type: ANDA
Sponsor: NATCO 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 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
A200482-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2012-12-31
A200482-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL			2012-12-31

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	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2012-12-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2012-12-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200482-001	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	A200482-002	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	A200482-001	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	A200482-002	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	A200482-001	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	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200482-002	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	A200482-001	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	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200482-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200482-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2012-12-31	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200482-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200482-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200482-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200482-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200482-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200482-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200482-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A200482-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200482-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200482-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200482-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A200482-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200482-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A200482-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A200482-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200482-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A200482-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200482-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A200482-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200482-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200482-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200482-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A200482-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200482-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A200482-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200482-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A200482-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200482-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A200482-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200482-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A200482-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200482-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A200482-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200482-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200482-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200482-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A200482-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200482-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A200482-002	AB	1	`ea1830bbd6c7…`

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 2 of 3 · 42 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	74971372-75c6-4682-adbf-1c8e7b748fc1	2024-10-01	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	03b5a887-d689-48a6-bd41-ae1ab4ae4990	2024-04-05	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	01762e5f-db9a-49b3-8da1-60967970a318	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Golden State Medical Supply, Inc.	075f47ee-88d1-102b-e063-6394a90acbf8	2024-03-25	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	2337e102-8df0-4e7f-81d8-5cb86cd48674	2024-02-19	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Rising Pharma Holdings, Inc.	222f77ff-d3f7-40f9-989c-e5902f44ef1e	2024-02-17	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Aurobindo Pharma Limited	fa0f65b8-96b0-49e4-ac47-9a86fb4aa5f1	2024-02-17	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	NuCare Pharmaceuticals,Inc.	106dd370-c09c-556a-e063-6394a90acfed	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	80c124ab-a083-4184-ba6b-199a7681b5d1	2023-09-01	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	65ae33a2-975f-4a4e-a1a5-42fe451a2434	2023-03-23	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
rizatriptan benzoate	RIZATRIPTAN BENZOATE	Macleods Pharmaceuticals Limited	57ed2505-28f1-4292-b3c3-a49bf0f7c683	2023-02-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: rizatriptan benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	A-S Medication Solutions	5001b8cc-8e52-4a00-a830-3b2f79766a03	2023-02-06	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Unichem Pharmaceuticals (USA), Inc.	35f26d3c-268b-4114-9b5b-1c2e0b9ddfd5	2022-11-22	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Ascend Laboratories, LLC	07e66554-bc85-4853-9f40-1249617630a9	2022-09-30	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
rizatriptan benzoate	RIZATRIPTAN BENZOATE	Glenmark Pharmaceuticals Inc., USA	99c66300-bd75-4b31-9fab-88c6e4b12688	2022-09-14	Warnings, Adverse reactions	Name fallback brand name: rizatriptan benzoate generic name: RIZATRIPTAN BENZOATE
rizatriptan benzoate	RIZATRIPTAN BENZOATE	Glenmark Pharmaceuticals Inc., USA	4de33a24-db69-444a-b04d-c69ccba57ab2	2022-09-14	Warnings, Adverse reactions	Name fallback brand name: rizatriptan benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Proficient Rx LP	4a5b43f6-a5ea-4d6f-941f-3c19f242c896	2022-05-01	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Cipla USA Inc.	f462a507-921c-41c2-93ba-36003b6e8914	2022-01-13	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Bionpharma Inc.,	91e160d6-f23f-e5e0-baec-908b2d25ce3c	2021-03-02	Warnings, Adverse reactions	Name fallback brand name: RIZATRIPTAN BENZOATE generic name: RIZATRIPTAN BENZOATE
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Unichem Pharmaceuticals (USA), Inc.	3cdeccf6-36dd-4a9e-9687-2f7cce47af5f	2020-04-08	Warnings, Adverse reactions	Name fallback brand name: Rizatriptan Benzoate generic name: RIZATRIPTAN BENZOATE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45865-825	Rizatriptan Benzoate	Rizatriptan Benzoate	Medsource Pharmaceuticals	ANDA	Current
45865-825	Rizatriptan Benzoate	Rizatriptan Benzoate	Medsource Pharmaceuticals	ANDA	Current
50090-3921	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
50090-3921	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
50090-3921	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
51991-354	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-354	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-354	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-354	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-354	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-355	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-355	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-355	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-355	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current
51991-355	Rizatriptan Benzoate	Rizatriptan Benzoate	Breckenridge Pharmaceutical, Inc.	ANDA	Current