Application 077087

Type: ANDA
Sponsor: FOSUN PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEFLUNOMIDE	LEFLUNOMIDE	TABLET;ORAL	10MG	No	No
002	LEFLUNOMIDE	LEFLUNOMIDE	TABLET;ORAL	20MG	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
A077087-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2005-09-13
A077087-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2005-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077087-001	AB
A077087-002	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 · 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	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077087-001	LEFLUNOMIDE	10MG	TABLET / ORAL		2005-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077087-002	LEFLUNOMIDE	20MG	TABLET / ORAL		2005-09-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A077087-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077087-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077087-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077087-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077087-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A077087-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077087-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A077087-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077087-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A077087-002	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077087-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077087-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077087-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A077087-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077087-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A077087-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077087-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077087-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077087-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077087-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077087-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077087-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077087-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077087-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077087-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A077087-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077087-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A077087-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077087-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077087-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077087-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A077087-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A077087-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A077087-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077087-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A077087-002	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077087-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A077087-002	AB	1	`a50c72e98297…`

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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Leflunomide	LEFLUNOMIDE	Burel Pharmaceuticals, LLC	fc044417-cd9a-42f6-8a3d-a14e7c2f81a2	2026-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	e76d7767-744f-4e52-956d-e59f7a924826	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	91712aad-d96c-4ef0-97e7-b31ed18ca6d8	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	8b365514-c859-ff93-e053-2a95a90ac698	2026-01-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEFLUNOMIDE generic name: LEFLUNOMIDE
LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	af836cd0-da42-772e-e053-2995a90ac103	2026-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEFLUNOMIDE generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	Chartwell RX, LLC	006b5bf4-97c0-48dc-8e5e-3c6f64d7bdc1	2025-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	40dd071a-d07f-452f-bf1a-2a23b9d22ca4	2025-11-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	Lupin Pharmaceuticals, Inc.	5d48fded-b43b-461a-8488-ca1da5c41a03	2025-10-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	fa5f71b3-6a56-4616-baf7-4b761023b2a9	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	d0fb9685-9e54-44e5-b543-1077e1a620c6	2025-10-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
LEFLUNOMIDE	LEFLUNOMIDE	Apotex Corp.	753453c5-8a7a-878e-3ce7-1d1edce718a9	2025-09-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: LEFLUNOMIDE generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	KVK-Tech, Inc.	a48e6ef2-48ad-4fcf-9e67-dbba83ab0b79	2025-06-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
Arava	LEFLUNOMIDE	sanofi-aventis U.S. LLC	320f63f2-fac3-4aee-aff8-85724e00ef52	2025-06-04	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	A-S Medication Solutions	d6f5c510-9ec2-4e2d-b134-25c35bd23fee	2025-04-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	NuCare Pharmaceuticals, Inc.	2b5c98d0-de59-85f6-e063-6394a90ab67a	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
leflunomide	LEFLUNOMIDE	NuCare Pharmaceuticals, Inc.	2b5f387e-b52b-ad80-e063-6394a90a56d5	2025-01-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	A-S Medication Solutions	0a4f8671-b632-4cc5-8dc9-6b863e62b467	2025-01-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	e85c4eed-794c-409b-aed5-3c857b14b1fb	2024-10-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	Bryant Ranch Prepack	acf3efe4-0d70-4718-9c50-789d69ab215d	2024-09-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE
Leflunomide	LEFLUNOMIDE	Alembic Pharmaceuticals Inc.	c288d1d3-3fbe-4c34-a28a-923d515809b3	2024-08-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Leflunomide generic name: LEFLUNOMIDE

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72266-132	Leflunomide	Leflunomide	Fosun Pharma USA Inc.	ANDA	Current
72266-133	Leflunomide	Leflunomide	Fosun Pharma USA Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
23859	ORIG	2010-08-09
9002	ORIG	2005-09-15