Application 077667

Type: ANDA
Sponsor: APOTEX INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MODAFINIL	MODAFINIL	TABLET;ORAL	100MG	No	No
002	MODAFINIL	MODAFINIL	TABLET;ORAL	200MG	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
A077667-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2014-02-03
A077667-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2014-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077667-001	AB
A077667-002	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	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077667-001	MODAFINIL	100MG	TABLET / ORAL	AB	2014-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077667-002	MODAFINIL	200MG	TABLET / ORAL	AB	2014-02-03	`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	A077667-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077667-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077667-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077667-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077667-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077667-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077667-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077667-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077667-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077667-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077667-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077667-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077667-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077667-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077667-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077667-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077667-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077667-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077667-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077667-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077667-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077667-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077667-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077667-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077667-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077667-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077667-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077667-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077667-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Apotex Corp.	944daf47-49a6-93ca-e348-4a0f1b6d937e	2026-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667 ndc (product): 60505-2527 ndc (product): 60505-2526
Modafinil	MODAFINIL	Golden State Medical Supply, Inc.	1d4c6858-5b2f-f216-e063-6394a90aad5d	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667
Modafinil	MODAFINIL	Major Pharmaceuticals	4a7ab52b-db31-4774-a06a-b11f2bb60662	2025-03-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667 ndc (product): 0904-6791 ndc (product): 0904-6792
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2023-01-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077667 application number: ANDA077667

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 22 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6791	Modafinil	modafinil	Major Pharmaceuticals	ANDA	Current
0904-6791	Modafinil	modafinil	Major Pharmaceuticals	ANDA	Current
0904-6792	Modafinil	modafinil	Major Pharmaceuticals	ANDA	Current
0904-6792	Modafinil	modafinil	Major Pharmaceuticals	ANDA	Current
50090-4144	Modafinil	modafinil	A-S Medication Solutions	ANDA	Current
55700-695	Modafinil	modafinil	Quality Care Products, LLC	ANDA	Current
55700-695	Modafinil	modafinil	Quality Care Products, LLC	ANDA	Current
60429-581	Modafinil	modafinil	Golden State Medical Supply, Inc.	ANDA	Current
60429-581	Modafinil	modafinil	Golden State Medical Supply, Inc.	ANDA	Current
60429-582	Modafinil	modafinil	Golden State Medical Supply, Inc.	ANDA	Current
60429-582	Modafinil	modafinil	Golden State Medical Supply, Inc.	ANDA	Current
60505-2526	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2526	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2526	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2526	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2526	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2527	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2527	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2527	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2527	Modafinil	modafinil	Apotex Corp.	ANDA	Current
60505-2527	Modafinil	modafinil	Apotex Corp.	ANDA	Current
71335-0259	Modafinil	modafinil	Bryant Ranch Prepack	ANDA	Current