Application 200751

Type: ANDA
Sponsor: LUPIN LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	50MG	No	No
002	ARMODAFINIL	ARMODAFINIL	TABLET; ORAL	100MG	No	No
003	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	150MG	No	No
004	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	200MG	No	No
005	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A200751-001	ARMODAFINIL	ARMODAFINIL	50MG	TABLET / ORAL	2016-11-28
A200751-003	ARMODAFINIL	ARMODAFINIL	150MG	TABLET / ORAL	2016-11-28
A200751-004	ARMODAFINIL	ARMODAFINIL	200MG	TABLET / ORAL	2016-11-28
A200751-005	ARMODAFINIL	ARMODAFINIL	250MG	TABLET / ORAL	2016-11-28

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 5 · 168 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	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL		2016-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL		2016-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL		2016-11-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL		2016-11-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2016-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-003	ARMODAFINIL	150MG	TABLET / ORAL	AB	2016-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-004	ARMODAFINIL	200MG	TABLET / ORAL	AB	2016-11-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-005	ARMODAFINIL	250MG	TABLET / ORAL	AB	2016-11-28	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 160 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	A200751-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200751-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200751-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200751-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200751-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200751-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200751-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200751-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200751-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200751-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200751-005	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200751-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200751-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200751-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A200751-005	AB	1	`d06236e962d9…`

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	93b9f9a4-66d9-4ed9-8f2f-903e416e900d	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Preferred Pharmaceuticals Inc.	4128759d-ed7c-4130-b24c-a0541f2b9e7f	2026-03-06	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	58e33a21-7816-4fa9-9fc7-c559426ad2b9	2026-02-04	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Nuvigil	ARMODAFINIL	Golden State Medical Supply, Inc.	3dd49302-f757-d945-e063-6294a90afcba	2025-09-02	Warnings, Adverse reactions	Name fallback generic name: ARMODAFINIL
Nuvigil	ARMODAFINIL	Apotex Corp.	a69631d0-1263-769e-b232-4ab9160e0fa3	2025-08-18	Warnings, Adverse reactions	Name fallback generic name: ARMODAFINIL
ARMODAFINIL	ARMODAFINIL	DirectRx	ddd06dab-0855-5b4e-e053-2a95a90a5e67	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: ARMODAFINIL generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Direct_Rx	facd329b-1925-61df-e053-6294a90ab738	2025-01-22	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
ARMODAFINIL	ARMODAFINIL	direct rx	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	2025-01-20	Warnings, Adverse reactions	Name fallback brand name: ARMODAFINIL generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Quality Care Products LLC	98338994-7818-4b86-ae98-cd08fa700879	2024-12-17	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	cbe7c0d9-dfd2-4000-bd76-7fe3454ce64f	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Aurobindo Pharma Limited	23da56b8-7552-4362-a1ab-e794c131194c	2024-02-02	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Natco Pharma USA LLC	de2f0921-e791-426c-9192-2b7162e2158c	2023-12-05	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Teva Pharmaceuticals USA, Inc.	b3cac300-c3d2-4189-a410-2aaf3773c090	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Sandoz Inc	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL
Nuvigil	ARMODAFINIL	Cephalon, LLC	d878aed0-ddbf-8fa1-abf7-d3e480260845	2022-12-31	Warnings, Adverse reactions	Name fallback generic name: ARMODAFINIL
Armodafinil	ARMODAFINIL	Mylan Pharmaceuticals Inc.	de0799f7-7644-4057-a7da-75436f978c61	2018-09-17	Warnings, Adverse reactions	Name fallback brand name: Armodafinil generic name: ARMODAFINIL

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
61919-770	Armodafinil	Armodafinil	Direct_Rx	ANDA	Current
61919-770	Armodafinil	Armodafinil	Direct_Rx	ANDA	Current
68180-569	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-569	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-569	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-571	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-571	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-571	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-572	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-572	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-572	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-573	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-573	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-573	Armodafinil	Armodafinil	Lupin Pharmaceuticals, Inc.	ANDA	Current
71335-0681	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current
71335-0681	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current
71335-0681	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current
71335-0710	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current
71335-0710	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current
71335-0710	Armodafinil	Armodafinil	Bryant Ranch Prepack	ANDA	Current