Application 205095

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RUFINAMIDE	RUFINAMIDE	TABLET;ORAL	200MG	No	No
002	RUFINAMIDE	RUFINAMIDE	TABLET;ORAL	400MG	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
A205095-001	RUFINAMIDE	RUFINAMIDE	200MG	TABLET / ORAL	AB		2016-05-16
A205095-002	RUFINAMIDE	RUFINAMIDE	400MG	TABLET / ORAL	AB		2016-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205095-001	AB
A205095-002	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	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL		2016-05-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL		2016-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205095-001	RUFINAMIDE	200MG	TABLET / ORAL	AB	2016-05-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205095-002	RUFINAMIDE	400MG	TABLET / ORAL	AB	2016-05-16	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 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	A205095-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205095-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205095-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205095-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205095-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205095-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205095-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205095-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205095-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205095-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205095-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205095-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205095-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205095-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205095-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205095-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205095-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205095-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205095-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205095-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205095-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205095-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205095-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205095-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205095-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205095-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205095-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205095-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205095-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205095-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205095-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205095-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205095-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205095-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A205095-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205095-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205095-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A205095-002	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205095-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205095-002	AB	1	`6a51e52b5d6a…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rufinamide	RUFINAMIDE	Novadoz Pharmaceuticals LLC	924ffdf9-ce5f-4989-9a43-78a03ba3eaed	2026-06-12	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
rufinamide	RUFINAMIDE	Glenmark Pharmaceuticals Inc., USA	da9ee326-a383-4d46-9d4e-fcc2be3d2680	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	American Health Packaging	1a0b80de-754d-4e60-b5a9-b6daa323bf58	2026-01-06	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
RUFINAMIDE	RUFINAMIDE	Lupin Pharmaceuticals, Inc.	2c2c8d41-1ae4-453a-b628-954ee0b3be5c	2025-12-26	Warnings, Adverse reactions	Name fallback brand name: RUFINAMIDE generic name: RUFINAMIDE
RUFINAMIDE	RUFINAMIDE	Aurobindo Pharma Limited	444544f0-7622-4eef-b218-f241bd50d4af	2025-12-11	Warnings, Adverse reactions	Name fallback brand name: RUFINAMIDE generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Bionpharma Inc.	e2ba061a-49f0-4330-b0f0-00f2c3725625	2025-08-26	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Aurobindo Pharma Limited	d9ffc833-d902-41cb-8e8e-6bbba8e65b9e	2025-07-19	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Lupin Pharmaceuticals, Inc.	1e671632-d5bd-499a-ba06-0d1dc0d99622	2025-05-12	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	NorthStar RxLLC	b682021c-74c3-4cc8-84af-acd94438397a	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Ascend Laboratories, LLC	a02ca527-bd8f-49ef-89fa-91fac154bffe	2024-03-28	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Camber Pharmaceuticals, Inc.	1c2f9bf2-1711-4975-af02-32614db25add	2023-12-28	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
RUFINAMIDE	RUFINAMIDE	Micro Labs Limited	12fc41f9-b6a9-4bbd-afbe-5d269f5a42f6	2023-05-17	Warnings, Adverse reactions	Name fallback brand name: RUFINAMIDE generic name: RUFINAMIDE
Banzel	RUFINAMIDE	Eisai Inc.	0a3fa925-1abd-458a-bd57-4ae780a1ef2d	2022-12-15	Warnings, Adverse reactions	Name fallback generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Camber Pharmaceuticals, Inc.	afe24968-e078-46d6-a776-b2608734e03e	2021-06-02	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Hikma Pharmaceuticals USA Inc.	56316809-6e73-4717-990b-fc84bf6bf433	2021-05-31	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE
Rufinamide	RUFINAMIDE	Hikma Pharmaceuticals USA Inc.	8ef75997-06f6-441f-8320-a23bc13ca2d9	2020-09-05	Warnings, Adverse reactions	Name fallback brand name: Rufinamide generic name: RUFINAMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-2330	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2330	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2330	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2330	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2331	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2331	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2331	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-2331	Rufinamide	rufinamide	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19622	ORIG	2016-05-20
32628	ORIG	2016-05-18