Application 207196

Type: ANDA
Sponsor: APPCO

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 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
A207196-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2017-08-16
A207196-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2017-08-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207196-001	AB
A207196-002	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	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207196-001	MODAFINIL	100MG	TABLET / ORAL	AB	2017-08-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207196-002	MODAFINIL	200MG	TABLET / ORAL	AB	2017-08-16	`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	A207196-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207196-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207196-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207196-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207196-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207196-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207196-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207196-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207196-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207196-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207196-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207196-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207196-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207196-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207196-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207196-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207196-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207196-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207196-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207196-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207196-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207196-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207196-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207196-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207196-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207196-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207196-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207196-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207196-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207196-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207196-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207196-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207196-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207196-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207196-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207196-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207196-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207196-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207196-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207196-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Preferred Pharmaceuticals Inc.	60ec6e2a-2576-498f-9a8c-fddc53d4a44c	2026-07-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207196 application number: ANDA207196
Modafinil	MODAFINIL	Bryant Ranch Prepack	3f733d7f-1213-4534-9433-0eb99a5abc2c	2024-09-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207196 application number: ANDA207196
Modafinil	MODAFINIL	Bryant Ranch Prepack	dd1454b3-8599-4dfa-aaf7-b8a3ebe85acd	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207196 application number: ANDA207196
Modafinil	MODAFINIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1a309416-bd6a-45b1-982f-b689b097453d	2024-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207196 application number: ANDA207196 ndc (product): 23155-604 ndc (product): 23155-605

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-604	Modafinil	Modafinil	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-604	Modafinil	Modafinil	Heritage Pharmaceuticals Inc	ANDA	Current
23155-604	Modafinil	Modafinil	Heritage Pharmaceuticals Inc	ANDA	Current
23155-604	Modafinil	Modafinil	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-605	Modafinil	Modafinil	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current
23155-605	Modafinil	Modafinil	Heritage Pharmaceuticals Inc	ANDA	Current
23155-605	Modafinil	Modafinil	Heritage Pharmaceuticals Inc	ANDA	Current
23155-605	Modafinil	Modafinil	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	ANDA	Current