Application 202566

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A202566-001	MODAFINIL	MODAFINIL	100MG	TABLET / ORAL	AB		2012-09-27
A202566-002	MODAFINIL	MODAFINIL	200MG	TABLET / ORAL	AB		2012-09-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202566-001	AB
A202566-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202566-001	MODAFINIL	100MG	TABLET / ORAL	AB	2012-09-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202566-002	MODAFINIL	200MG	TABLET / ORAL	AB	2012-09-27	`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	A202566-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202566-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202566-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202566-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202566-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202566-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202566-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202566-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202566-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202566-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202566-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202566-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202566-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202566-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202566-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202566-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202566-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202566-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202566-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202566-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202566-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202566-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202566-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202566-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202566-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202566-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202566-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202566-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202566-002	AB	1	`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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Modafinil	MODAFINIL	AvPAK	4790bbe9-d753-1067-02ee-9536011650d9	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 50268-570 ndc (product): 50268-571
Modafinil	MODAFINIL	American Health Packaging	928a3ab6-b53c-4924-882c-9f2f49aba0f1	2024-10-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 68084-721 ndc (product): 68084-621
Modafinil	MODAFINIL	Bryant Ranch Prepack	963aa6be-5aed-4865-b375-8c2c3102e7bc	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 71335-1173
Modafinil	MODAFINIL	Bryant Ranch Prepack	f1ff7c6d-df04-48dd-a971-454d38e7d997	2024-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 71335-1122
Modafinil	MODAFINIL	Bryant Ranch Prepack	f0c43046-fc86-4b62-bd0f-704a6894625d	2024-07-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 63629-7315
Modafinil	MODAFINIL	NuCare Pharmaceuticals,Inc.	98e54b10-8ae0-7c43-e053-2a95a90ae8bb	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 68071-5121
Modafinil	MODAFINIL	Rising Pharma Holdings, Inc.	4b63aac6-4385-44a3-8390-cdbb0b4b5fe0	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 57237-154 ndc (product): 57237-155
Modafinil	MODAFINIL	Aurobindo Pharma Limited	f51ca007-3955-4540-a88a-0ddae8d8e8ab	2024-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 65862-601 ndc (product): 65862-602
Modafinil	MODAFINIL	Proficient Rx LP	d97684d7-c236-451e-99bd-b8df4bf36643	2023-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 71205-544
Modafinil	MODAFINIL	Proficient Rx LP	ccf7836d-c131-4e7d-a339-fbf99fe7f449	2023-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202566 application number: ANDA202566 ndc (product): 71205-477

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 54 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2472	Modafinil	Modafinil	A-S Medication Solutions	ANDA	Current
50090-2473	Modafinil	Modafinil	A-S Medication Solutions	ANDA	Current
50090-2473	Modafinil	Modafinil	A-S Medication Solutions	ANDA	Current
50268-570	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-570	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-570	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-570	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-571	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-571	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-571	Modafinil	Modafinil	AvPAK	ANDA	Current
50268-571	Modafinil	Modafinil	AvPAK	ANDA	Current
57237-154	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
57237-154	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
57237-154	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
57237-155	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
57237-155	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
57237-155	Modafinil	Modafinil	Rising Health, LLC	ANDA	Current
63629-4998	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
63629-4998	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
63629-7315	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
63629-7315	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
63629-7315	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
65862-601	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-601	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-601	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-601	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-601	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-602	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-602	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-602	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-602	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
65862-602	Modafinil	Modafinil	Aurobindo Pharma Limited	ANDA	Current
68071-5121	Modafinil	Modafinil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-5121	Modafinil	Modafinil	NuCare Pharmaceuticals,Inc.	ANDA	Current
68084-621	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-621	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-621	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-621	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-721	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-721	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-721	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68084-721	Modafinil	Modafinil	American Health Packaging	ANDA	Current
68788-7432	Modafinil	Modafinil	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7432	Modafinil	Modafinil	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7432	Modafinil	Modafinil	Preferred Pharmaceuticals, Inc.	ANDA	Current
68788-7432	Modafinil	Modafinil	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-477	Modafinil	Modafinil	Proficient Rx LP	ANDA	Current
71205-544	Modafinil	Modafinil	Proficient Rx LP	ANDA	Current
71335-1122	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1122	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1122	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1173	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1173	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current
71335-1173	Modafinil	Modafinil	Bryant Ranch Prepack	ANDA	Current