Application 091369

Type: ANDA
Sponsor: ALEMBIC PHARMS LTD

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 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
A091369-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2011-11-21
A091369-002	LEFLUNOMIDE	LEFLUNOMIDE	20MG	TABLET / ORAL	AB		2011-11-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091369-001	AB
A091369-002	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 · 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	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091369-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2011-11-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091369-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2011-11-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A091369-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091369-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091369-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091369-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091369-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091369-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091369-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091369-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091369-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091369-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091369-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091369-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091369-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091369-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091369-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091369-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091369-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091369-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091369-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091369-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091369-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091369-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091369-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091369-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091369-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091369-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091369-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091369-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091369-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091369-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091369-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091369-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091369-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091369-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091369-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091369-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091369-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091369-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091369-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091369-002	AB	1	`bb7c543d1eb4…`

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
Leflunomide	LEFLUNOMIDE	Alembic Pharmaceuticals Inc.	c288d1d3-3fbe-4c34-a28a-923d515809b3	2024-08-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091369 application number: ANDA091369 ndc (product): 62332-062 ndc (product): 62332-061
Leflunomide	LEFLUNOMIDE	Alembic Pharmaceuticals Limited	f6a4107e-b393-45ed-8e5a-70af5bd53826	2023-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 091369 application number: ANDA091369 ndc (product): 46708-437 ndc (product): 46708-436

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
13811-677	Leflunomide	Leflunomide	Trigen Laboratories, LLC	ANDA	Current
13811-677	Leflunomide	Leflunomide	Trigen Laboratories, LLC	ANDA	Current
13811-678	Leflunomide	Leflunomide	Trigen Laboratories, LLC	ANDA	Current
13811-678	Leflunomide	Leflunomide	Trigen Laboratories, LLC	ANDA	Current
46708-436	Leflunomide	Leflunomide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-436	Leflunomide	Leflunomide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-437	Leflunomide	Leflunomide	Alembic Pharmaceuticals Limited	ANDA	Current
46708-437	Leflunomide	Leflunomide	Alembic Pharmaceuticals Limited	ANDA	Current
62332-061	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-061	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-061	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-062	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-062	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-062	Leflunomide	Leflunomide	Alembic Pharmaceuticals Inc.	ANDA	Current