Application 204339

Type: ANDA
Sponsor: INVAGEN PHARMS

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 42.

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
A204339-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL			2013-07-01
A204339-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL			2013-07-01

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 · 84 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	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL		2013-07-01	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL		2013-07-01	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204339-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2013-07-01	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204339-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2013-07-01	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 52 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204339-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204339-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A204339-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204339-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A204339-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204339-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A204339-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204339-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A204339-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204339-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A204339-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204339-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204339-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204339-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A204339-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204339-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A204339-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204339-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A204339-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204339-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A204339-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204339-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A204339-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204339-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A204339-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204339-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204339-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204339-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A204339-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204339-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A204339-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204339-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204339-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204339-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204339-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204339-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204339-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204339-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204339-002	AB	1	`3f0d92c62455…`

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 · 2 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): 204339 application number: ANDA204339 ndc (product): 61919-394
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Cipla USA Inc.	f462a507-921c-41c2-93ba-36003b6e8914	2022-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204339 application number: ANDA204339 ndc (product): 69097-865 ndc (product): 69097-866

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
31722-462	Rizatriptan Benzoate	Rizatriptan Benzoate	Camber Pharmaceuticals, Inc.	ANDA	Current
31722-463	Rizatriptan Benzoate	Rizatriptan Benzoate	Camber Pharmaceuticals, Inc.	ANDA	Current
53002-1713	Rizatriptan Benzoate	Rizatriptan Benzoate	RPK Pharmaceuticals, Inc.	ANDA	Current
53002-1713	Rizatriptan Benzoate	Rizatriptan Benzoate	RPK Pharmaceuticals, Inc.	ANDA	Current
61919-394	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	ANDA	Current
61919-394	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	DIRECT RX	ANDA	Current
63629-7433	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
63629-7433	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
63629-7433	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
69097-865	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-865	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-865	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-865	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-865	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-866	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-866	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-866	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-866	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
69097-866	Rizatriptan Benzoate	Rizatriptan Benzoate	Cipla USA Inc.	ANDA	Current
71335-0810	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-0810	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-0810	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
76282-462	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-462	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-462	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-463	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-463	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current
76282-463	Rizatriptan Benzoate	Rizatriptan Benzoate	Exelan Pharmaceuticals Inc.	ANDA	Current