Application 021875

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUVIGIL	ARMODAFINIL	TABLET;ORAL	50MG	Yes	No
002	NUVIGIL	ARMODAFINIL	TABLET;ORAL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
003	NUVIGIL	ARMODAFINIL	TABLET;ORAL	150MG	Yes	No
004	NUVIGIL	ARMODAFINIL	TABLET;ORAL	250MG	Yes	Yes
005	NUVIGIL	ARMODAFINIL	TABLET;ORAL	200MG	Yes	No

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

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021875-001	NUVIGIL	ARMODAFINIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15
N021875-002	NUVIGIL	ARMODAFINIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26
N021875-003	NUVIGIL	ARMODAFINIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15
N021875-004	NUVIGIL	ARMODAFINIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15
N021875-005	NUVIGIL	ARMODAFINIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N021875-001	AB
N021875-003	AB
N021875-004	AB
N021875-005	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 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	NUVIGIL	50MG	TABLET / ORAL	AB	RLD	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	NUVIGIL	100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	2009-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	NUVIGIL	150MG	TABLET / ORAL	AB	RLD	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	NUVIGIL	250MG	TABLET / ORAL	AB	RLD, RS	2007-06-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	NUVIGIL	200MG	TABLET / ORAL	AB	RLD	2009-03-26	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	N021875-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021875-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021875-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021875-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021875-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021875-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021875-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021875-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021875-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	AB	1	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 590 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-001	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-002	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-002	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-003	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-004	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021875-005	7132570*PED	2024-06-18	Pediatric extension	`d8e5a09893c0…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nuvigil	ARMODAFINIL	Golden State Medical Supply, Inc.	3dd49302-f757-d945-e063-6294a90afcba	2025-09-02	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Nuvigil	ARMODAFINIL	Apotex Corp.	a69631d0-1263-769e-b232-4ab9160e0fa3	2025-08-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
ARMODAFINIL	ARMODAFINIL	DirectRx	ddd06dab-0855-5b4e-e053-2a95a90a5e67	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875 ndc (product): 72189-353
ARMODAFINIL	ARMODAFINIL	direct rx	b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19	2025-01-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875 ndc (product): 72189-261
Armodafinil	ARMODAFINIL	Quality Care Products LLC	98338994-7818-4b86-ae98-cd08fa700879	2024-12-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Armodafinil	ARMODAFINIL	Teva Pharmaceuticals USA, Inc.	b3cac300-c3d2-4189-a410-2aaf3773c090	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Armodafinil	ARMODAFINIL	Sandoz Inc	a3341ec8-1ad4-49e2-922b-13d1b30c8c1d	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875
Nuvigil	ARMODAFINIL	Cephalon, LLC	d878aed0-ddbf-8fa1-abf7-d3e480260845	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 021875 application number: NDA021875 ndc (product): 63459-225 ndc (product): 63459-220 ndc (product): 63459-215

NDC Listings For This Application#

NDC listings for this application page 2 of 2 · 128 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63459-215	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-215	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-220	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, LLC	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63459-225	Nuvigil	Armodafinil	Cephalon, Inc.	NDA	Current
63629-7390	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7390	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7403	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
63629-7403	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
68788-7176	Armodafinil	Armodafinil	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7176	Armodafinil	Armodafinil	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7176	Armodafinil	Armodafinil	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7176	Armodafinil	Armodafinil	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7176	Armodafinil	Armodafinil	Preferred Pharmaceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7222	Armodafinil	Armodafinil	Preferred Pharmacceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7222	Armodafinil	Armodafinil	Preferred Pharmacceuticals Inc.	NDA AUTHORIZED GENERIC	Current
68788-7222	Armodafinil	Armodafinil	Preferred Pharmacceuticals Inc.	NDA AUTHORIZED GENERIC	Current
71335-1842	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
71335-1857	Armodafinil	Armodafinil	Bryant Ranch Prepack	NDA AUTHORIZED GENERIC	Current
72189-261	ARMODAFINIL	ARMODAFINIL	direct rx	NDA AUTHORIZED GENERIC	Current
72189-353	ARMODAFINIL	ARMODAFINIL	DirectRx	NDA AUTHORIZED GENERIC	Current
72189-353	ARMODAFINIL	ARMODAFINIL	DirectRx	NDA AUTHORIZED GENERIC	Current
72789-060	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-060	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-060	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-126	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-126	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current
72789-126	Armodafinil	Armodafinil	PD-Rx Pharmaceuticals, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
47154	SUPPL	2017-02-09
47134	SUPPL	2017-02-07
6358	SUPPL	2015-04-17
16501	SUPPL	2015-04-16
23307	ORIG	2013-07-26
37802	SUPPL	2013-07-15
6356	SUPPL	2013-07-02
28755	SUPPL	2012-01-19
6357	SUPPL	2012-01-19
28754	SUPPL	2010-10-25
28753	SUPPL	2010-10-25
28751	SUPPL	2010-10-25
16500	SUPPL	2010-10-25
16499	SUPPL	2010-10-25
16498	SUPPL	2010-10-25
28752	SUPPL	2009-04-01
21852	ORIG	2009-03-05
28750	ORIG	2007-07-05
37801	ORIG	2007-06-27