Application 090543

Type: ANDA
Sponsor: HIKMA PHARMS

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 43.

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
A090543-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL			2012-09-26
A090543-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL			2012-09-26

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090543-001	MODAFINIL	100MG	TABLET / ORAL	2012-09-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090543-002	MODAFINIL	200MG	TABLET / ORAL	2012-09-26	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-07-19 19:46 UTC	2019-07	A090543-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090543-002	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 2 of 2 · 35 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	Proficient Rx LP	c332ea93-48d9-4c8a-a1ef-01c27a61350b	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	NuCare Pharmaceuticals,Inc.	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	2024-06-20	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Rising Pharma Holdings, Inc.	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	2024-05-27	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aurobindo Pharma Limited	f51ca007-3955-4540-a88a-0ddae8d8e8ab	2024-05-27	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bryant Ranch Prepack	dd1454b3-8599-4dfa-aaf7-b8a3ebe85acd	2024-04-03	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Viona Pharmaceuticals Inc	15739a31-2433-49b5-90ea-b974214f73be	2023-11-10	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Bionpharma Inc.	63604fef-0b80-40ce-8dbf-3384f1aee395	2023-07-21	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Proficient Rx LP	d97684d7-c236-451e-99bd-b8df4bf36643	2023-06-01	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	CIMA LABS INC.	9f3b0bd2-72a3-411f-aeec-b533373f1a97	2023-01-31	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	a4a27496-0f5a-4ea8-b48c-72fcb323dc8f	2023-01-16	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Proficient Rx LP	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2023-01-01	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Provigil	MODAFINIL	Cephalon, LLC	e16c26ad-7bc2-d155-3a5d-da83ad6492c8	2022-12-31	Warnings, Adverse reactions	Name fallback generic name: MODAFINIL
Modafinil	MODAFINIL	Alembic Pharmaceuticals Limited	5b8496fe-b647-4ce6-aeef-71245712e46f	2022-06-03	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
Modafinil	MODAFINIL	Alembic Pharmaceuticals Inc.	41f9ddbd-5228-4f0c-b0aa-2056af79a21e	2021-10-01	Warnings, Adverse reactions	Name fallback brand name: Modafinil generic name: MODAFINIL
modafinil	MODAFINIL	Aphena Pharma Solutions - Tennessee, LLC	cad4201c-133c-4a61-9d93-3c5e51695430	2017-12-19	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 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0143-9968	Modafinil	modafinil	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9968	Modafinil	modafinil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
0143-9969	Modafinil	modafinil	West-Ward Pharmaceuticals Corp	ANDA	Current
0143-9969	Modafinil	modafinil	Hikma Pharmaceuticals USA Inc.	ANDA	Current
59115-069	Modafinil	modafinil	Hikma Pharmaceutical	ANDA	Current
59115-069	Modafinil	modafinil	Hikma Pharmaceutical	ANDA	Current
59115-070	Modafinil	modafinil	Hikma Pharmaceutical	ANDA	Current
59115-070	Modafinil	modafinil	Hikma Pharmaceutical	ANDA	Current
71335-0811	Modafinil	modafinil	Bryant Ranch Prepack	ANDA	Current
71335-0811	Modafinil	modafinil	Bryant Ranch Prepack	ANDA	Current