Application 077090

Type: ANDA
Sponsor: APOTEX INC

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 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
A077090-001	LEFLUNOMIDE	LEFLUNOMIDE	10MG	TABLET / ORAL	AB		2005-09-13
A077090-002	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
A077090-001	AB
A077090-002	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	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077090-001	LEFLUNOMIDE	10MG	TABLET / ORAL	AB	2005-09-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077090-002	LEFLUNOMIDE	20MG	TABLET / ORAL	AB	2005-09-13	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A077090-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077090-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077090-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077090-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077090-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077090-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077090-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077090-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077090-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077090-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077090-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077090-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077090-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077090-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077090-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077090-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077090-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077090-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077090-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077090-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077090-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077090-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077090-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077090-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077090-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077090-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077090-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077090-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077090-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077090-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077090-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077090-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077090-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077090-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077090-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077090-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077090-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077090-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077090-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077090-002	AB	1	`782e0a99824c…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	8b365514-c859-ff93-e053-2a95a90ac698	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077090 application number: ANDA077090 ndc (product): 42291-420 ndc (product): 42291-421
LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	af836cd0-da42-772e-e053-2995a90ac103	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077090 application number: ANDA077090 ndc (product): 50268-478 ndc (product): 50268-477
LEFLUNOMIDE	LEFLUNOMIDE	Apotex Corp.	753453c5-8a7a-878e-3ce7-1d1edce718a9	2025-09-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077090 application number: ANDA077090 ndc (product): 60505-2503 ndc (product): 60505-2502

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-420	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE, Inc	ANDA	Current
42291-420	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	ANDA	Current
42291-420	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	ANDA	Current
42291-421	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE, Inc	ANDA	Current
42291-421	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	ANDA	Current
42291-421	LEFLUNOMIDE	LEFLUNOMIDE	AvKARE	ANDA	Current
50268-477	LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	ANDA	Current
50268-477	LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	ANDA	Current
50268-478	LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	ANDA	Current
50268-478	LEFLUNOMIDE	LEFLUNOMIDE	AvPAK	ANDA	Current
60505-2502	LEFLUNOMIDE	LEFLUNOMIDE	Apotex Corp.	ANDA	Current
60505-2503	LEFLUNOMIDE	LEFLUNOMIDE	Apotex Corp.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44341	ORIG	2010-08-09
9003	ORIG	2005-09-15