Application 076594

Type: ANDA
Sponsor: MYLAN PHARMS 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 44.

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
A076594-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL			2012-07-16
A076594-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL			2012-07-16

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 2 of 3 · 88 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
2019-12-13 00:20 UTC	2019-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076594-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-07-16	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076594-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-07-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076594-001	MODAFINIL	100MG	TABLET / ORAL		2012-07-16	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076594-002	MODAFINIL	200MG	TABLET / ORAL		2012-07-16	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A076594-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A076594-002	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076594-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076594-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A076594-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076594-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A076594-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076594-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A076594-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076594-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A076594-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076594-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A076594-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076594-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A076594-002	AB	1	`ea99ee380514…`

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 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	1a309416-bd6a-45b1-982f-b689b097453d	2026-09-03	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Apotex Corp.	944daf47-49a6-93ca-e348-4a0f1b6d937e	2026-07-21	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Preferred Pharmaceuticals Inc.	60ec6e2a-2576-498f-9a8c-fddc53d4a44c	2026-07-17	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Preferred Pharmaceuticals Inc.	013450dd-cd42-46c7-98d6-9a2925761978	2026-07-14	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Golden State Medical Supply, Inc.	1d4c6858-5b2f-f216-e063-6394a90aad5d	2026-03-16	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	4c9c4e61-517c-a9d2-e063-6394a90a58c7	2026-03-09	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	4aa3bdad-163f-fda1-e063-6394a90ae1d8	2026-02-12	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	AvPAK	4790bbe9-d753-1067-02ee-9536011650d9	2026-01-08	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	463bb960-a0b5-4ca4-e063-6294a90a683b	2025-12-18	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Golden State Medical Supply, Inc.	457662d8-b95c-d3af-e063-6294a90a883e	2025-12-08	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Provigil	MODAFINIL	Golden State Medical Supply, Inc.	3b8d1c32-dac9-50e6-e063-6394a90aa5a5	2025-10-16	Warnings, Adverse reactions	Name fallback generic name: MODAFINIL
Provigil	MODAFINIL	Apotex Corp	0391f182-1958-9fef-a944-53b229ce99e7	2025-08-27	Warnings, Adverse reactions	Name fallback generic name: MODAFINIL
Modafinil	MODAFINIL	Major Pharmaceuticals	4a7ab52b-db31-4774-a06a-b11f2bb60662	2025-03-11	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	2bc3cd03-2726-f693-e063-6294a90a7a03	2025-02-21	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	American Health Packaging	928a3ab6-b53c-4924-882c-9f2f49aba0f1	2024-10-31	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bryant Ranch Prepack	3f733d7f-1213-4534-9433-0eb99a5abc2c	2024-09-23	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bryant Ranch Prepack	963aa6be-5aed-4865-b375-8c2c3102e7bc	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Zydus Lifesciences Limited	f39820fb-8248-4d42-854c-6fe2d9b92d36	2024-08-16		Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bryant Ranch Prepack	f1ff7c6d-df04-48dd-a971-454d38e7d997	2024-07-09	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bryant Ranch Prepack	f0c43046-fc86-4b62-bd0f-704a6894625d	2024-07-08	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5573	Modafinil	modafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5575	Modafinil	modafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-831	Modafinil	modafinil	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-561	Modafinil	modafinil	Mylan Institutional Inc.	ANDA	Current
51079-561	Modafinil	modafinil	Mylan Institutional Inc.	ANDA	Current
51079-562	Modafinil	modafinil	Mylan Institutional Inc.	ANDA	Current
51079-562	Modafinil	modafinil	Mylan Institutional Inc.	ANDA	Current
68788-7408	Modafinil	modafinil	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7408	Modafinil	modafinil	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0997	Modafinil	modafinil	Bryant Ranch Prepack	ANDA	Current
71335-0997	Modafinil	modafinil	Bryant Ranch Prepack	ANDA	Current