Application 209613

Type: ANDA
Sponsor: AMNEAL PHARMS CO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TERIFLUNOMIDE	TERIFLUNOMIDE	TABLET;ORAL	7MG	No	No
002	TERIFLUNOMIDE	TERIFLUNOMIDE	TABLET;ORAL	14MG	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
A209613-001	TERIFLUNOMIDE	TERIFLUNOMIDE	7MG	TABLET / ORAL			2018-09-28
A209613-002	TERIFLUNOMIDE	TERIFLUNOMIDE	14MG	TABLET / ORAL			2018-09-28

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 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	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL	AB	2018-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL	AB	2018-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209613-001	TERIFLUNOMIDE	7MG	TABLET / ORAL		2018-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209613-002	TERIFLUNOMIDE	14MG	TABLET / ORAL		2018-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	A209613-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209613-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209613-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209613-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209613-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A209613-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209613-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209613-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209613-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209613-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209613-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209613-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209613-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209613-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209613-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209613-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209613-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209613-002	AB	1	`053a50430f4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2023-12-20 04:57 UTC	2023-12	A209613-001	PC	2023-09-08	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A209613-002	PC	2023-09-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209613-001	PC	2023-09-08	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209613-002	PC	2023-09-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209613-001	PC	2023-09-08	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209613-002	PC	2023-09-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209613-001	PC	2023-09-08	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209613-002	PC	2023-09-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209613-001	PC	2023-09-08	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209613-002	PC	2023-09-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209613-001	PC	2023-09-08	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A209613-002	PC	2023-09-08	`053a50430f4f…`

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
TERIFLUNOMIDE	TERIFLUNOMIDE	CONCORD BIOTECH LIMITED	2d2724f6-8812-4a26-b2ec-936b71f868e1	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TERIFLUNOMIDE generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Zydus Pharmaceuticals USA Inc.	cbf32b27-e63a-4544-9c1f-6564e82200e5	2026-04-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Aurobindo Pharma Limited	2fd80242-c607-4c50-b497-8259abb4a2f8	2026-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
TERIFLUNOMIDE	TERIFLUNOMIDE	Alembic Pharmaceuticals Inc.	8c1bc23b-a62b-4172-a603-8b97761514b4	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TERIFLUNOMIDE generic name: TERIFLUNOMIDE
teriflunomide	TERIFLUNOMIDE	Glenmark Pharmaceuticals Inc., USA	cb431ea0-ba0f-4b5d-a50d-f8c050762242	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: teriflunomide generic name: TERIFLUNOMIDE
Aubagio	TERIFLUNOMIDE	Genzyme Corporation	4650d12c-b9c8-4525-b07f-a2d773eca155	2026-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	AvKARE	f9c95ed7-130f-9455-e053-6394a90a182f	2026-01-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Accord Healthcare Inc.	246d42e5-5418-42ba-aff9-ae399b166c69	2025-12-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Teva Pharmaceuticals, Inc.	c424959d-00c9-4e76-aba6-cc7464d8e903	2024-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Biocon Pharma Inc.	37f04f8b-001e-66ff-4574-cc34cebce61c	2024-09-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Zydus Lifesciences Limited	58991a51-d40e-476f-8f5f-ac89e68e7107	2024-08-12		Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Natco Pharma USA LLC	8219b4a2-fb9d-4387-ba33-96d28aad71dd	2024-01-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Camber Pharmaceuticals, Inc.	9b25c24e-a4a9-43b4-a33f-75bef3a96d5f	2023-03-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
TERIFLUNOMIDE	TERIFLUNOMIDE	Alembic Pharmaceuticals Limited	2b084b44-f15b-4b16-b700-4382434f2136	2023-02-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: TERIFLUNOMIDE generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	MSN LABORATORIES PRIVATE LIMITED	63ba28ef-5055-461a-99ef-c49e8ece4b54	2023-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE
Teriflunomide	TERIFLUNOMIDE	Mylan Pharmaceuticals Inc.	1824aae5-58af-43da-8231-435c8f118bc0	2022-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Teriflunomide generic name: TERIFLUNOMIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69238-1303	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1303	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1303	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1303	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1303	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals LLC	ANDA	Current
69238-1304	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1304	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1304	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1304	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals NY LLC	ANDA	Current
69238-1304	Teriflunomide	Teriflunomide	Amneal Pharmaceuticals LLC	ANDA	Current