Application 020717

Type: NDA
Sponsor: CEPHALON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PROVIGIL	MODAFINIL	TABLET;ORAL	100MG	Yes	No
002	PROVIGIL	MODAFINIL	TABLET;ORAL	200MG	Yes	Yes

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
N020717-001	PROVIGIL	MODAFINIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24
N020717-002	PROVIGIL	MODAFINIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020717-001	AB
N020717-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	PROVIGIL	100MG	TABLET / ORAL	AB	RLD	1998-12-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-002	PROVIGIL	200MG	TABLET / ORAL	AB	RLD, RS	1998-12-24	`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	N020717-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020717-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020717-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020717-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020717-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020717-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020717-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-002	AB	1	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 118 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	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	7297346	2023-11-29	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	7297346	2023-11-29	Drug product	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020717-001	7297346	2023-11-29	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	7297346	2023-11-29	Drug product	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020717-001	7297346	2023-11-29	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	7297346	2023-11-29	Drug product	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020717-001	7297346	2023-11-29	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	7297346	2023-11-29	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020717-001	7297346	2023-11-29	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	7297346	2023-11-29	Drug product	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020717-002	7297346*PED	2024-05-29	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020717-001	7297346	2023-11-29	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020717-001	7297346*PED	2024-05-29	Pediatric extension	`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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Provigil	MODAFINIL	Golden State Medical Supply, Inc.	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2025-10-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Provigil	MODAFINIL	Apotex Corp	0391f182-1958-9fef-a944-53b229ce99e7	2025-08-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717
Modafinil	MODAFINIL	CIMA LABS INC.	9f3b0bd2-72a3-411f-aeec-b533373f1a97	2023-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717 ndc (product): 55253-801 ndc (product): 55253-802
Provigil	MODAFINIL	Cephalon, LLC	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	2022-12-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717 ndc (product): 63459-101 ndc (product): 63459-201
modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	cad4201c-133c-4a61-9d93-3c5e51695430	2017-12-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020717 application number: NDA020717 ndc (product): 43353-925

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 46 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
21695-234	PROVIGIL	MODAFINIL	Rebel Distributors Corp	NDA	Current
21695-235	PROVIGIL	MODAFINIL	Rebel Distributors Corp	NDA	Current
35356-372	PROVIGIL	modafinil	Lake Erie Medical Surgical & Supply DBA Quality Care Products LLC	NDA	Current
43353-925	modafinil	modafinil	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
43353-956	Modafinil	Modafinil	Aphena Pharma Solutions - Tennessee, LLC	NDA AUTHORIZED GENERIC	Current
49884-534	Modafinil	Modafinil	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
49884-535	Modafinil	Modafinil	Par Pharmaceutical Inc.	NDA AUTHORIZED GENERIC	Current
50436-0201	Provigil	Modafinil	Unit Dose Services	NDA	Current
50436-0201	Provigil	Modafinil	Unit Dose Services	NDA	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-801	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
55253-802	Modafinil	Modafinil	CIMA LABS INC.	NDA AUTHORIZED GENERIC	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, LLC	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, LLC	NDA	Current
63459-101	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, LLC	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, LLC	NDA	Current
63459-201	Provigil	Modafinil	Cephalon, Inc.	NDA	Current
68258-7981	modafinil	modafinil	Dispensing Solutions, Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
35216	SUPPL	2015-01-20
25626	SUPPL	2015-01-20
13285	SUPPL	2015-01-20
3192	SUPPL	2015-01-20
3194	SUPPL	2012-01-19
3193	SUPPL	2012-01-19
43675	SUPPL	2010-10-25
43674	SUPPL	2010-10-25
35215	SUPPL	2010-10-25
25625	SUPPL	2010-10-25
25624	SUPPL	2010-10-25
23180	SUPPL	2010-10-25
13284	SUPPL	2010-10-25
13283	SUPPL	2010-10-25
3191	SUPPL	2010-10-25
41612	SUPPL	2007-09-24
20875	SUPPL	2007-09-24
25623	SUPPL	2007-08-22
35214	SUPPL	2007-08-21
35213	SUPPL	2007-08-21
13282	SUPPL	2007-08-21
41611	SUPPL	2007-04-11
41610	SUPPL	2007-04-11
41609	SUPPL	2007-04-11
20874	SUPPL	2007-04-11
13281	SUPPL	2004-02-03
3189	SUPPL	2004-02-02
3190	SUPPL	2003-08-15
3188	SUPPL	2003-05-29
41608	ORIG	1998-12-24
25622	ORIG	1998-12-24
13280	ORIG	1998-12-24
52057	ORIG	1900-01-01
52056	ORIG	1900-01-01
52055	ORIG	1900-01-01
52054	ORIG	1900-01-01