Application 202931

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	TABLET;ORAL	EQ 2.5MG 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A202931-001	FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL			2014-08-28

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 2 · 41 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	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL		2014-08-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202931-001	FROVATRIPTAN SUCCINATE	EQ 2.5MG BASE	TABLET / ORAL	AB	2014-08-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

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	A202931-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202931-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202931-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202931-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202931-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202931-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202931-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202931-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202931-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202931-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202931-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202931-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202931-001	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	A202931-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202931-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202931-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202931-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202931-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202931-001	AB	1	`cb3db0bc1861…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FROVATRIPTAN SUCCINATE	FROVATRIPTAN SUCCINATE	Leading Pharma, LLC	d303af88-e0c1-4fb2-ba8e-83b7e6d163cd	2026-06-27	Warnings, Adverse reactions	Name fallback brand name: FROVATRIPTAN SUCCINATE generic name: FROVATRIPTAN SUCCINATE
frovatriptan succinate	FROVATRIPTAN SUCCINATE	Glenmark Pharmaceuticals Inc., USA	03a58215-dba7-4f63-8b98-d74d054a574a	2026-01-28	Warnings, Adverse reactions	Name fallback brand name: frovatriptan succinate generic name: FROVATRIPTAN SUCCINATE
FROVATRIPTAN	FROVATRIPTAN SUCCINATE	Ingenus Pharmaceuticals, LLC	92c91060-c06e-4a8a-b586-a3fb25c33433	2025-11-26	Warnings, Adverse reactions	Name fallback generic name: FROVATRIPTAN SUCCINATE
Frovatriptan	FROVATRIPTAN SUCCINATE	Amneal Pharmaceuticals NY LLC	94b996dc-ddc4-41ce-9a9f-3d91cb187473	2019-09-30	Warnings, Adverse reactions	Name fallback generic name: FROVATRIPTAN SUCCINATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3140	Frovatriptan	frovatriptan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3140	Frovatriptan	frovatriptan	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3140	Frovatriptan	frovatriptan	Mylan Pharmaceuticals Inc.	ANDA	Current