Application 200043

Type: ANDA
Sponsor: MYLAN PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	50MG	No	No
002	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	150MG	No	No
003	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	250MG	No	No
004	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	100MG	No	No
005	ARMODAFINIL	ARMODAFINIL	TABLET;ORAL	200MG	No	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	Approval date
A200043-001	ARMODAFINIL	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01
A200043-002	ARMODAFINIL	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01
A200043-003	ARMODAFINIL	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01
A200043-004	ARMODAFINIL	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09
A200043-005	ARMODAFINIL	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A200043-001	AB
A200043-002	AB
A200043-003	AB
A200043-004	AB
A200043-005	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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-001	ARMODAFINIL	50MG	TABLET / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-002	ARMODAFINIL	150MG	TABLET / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-003	ARMODAFINIL	250MG	TABLET / ORAL	AB	2012-06-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-004	ARMODAFINIL	100MG	TABLET / ORAL	AB	2019-05-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-005	ARMODAFINIL	200MG	TABLET / ORAL	AB	2019-05-09	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 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	A200043-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200043-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200043-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200043-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200043-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200043-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200043-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200043-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200043-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200043-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200043-005	AB	1	`2680178bc6a6…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Armodafinil	ARMODAFINIL	Bryant Ranch Prepack	58e33a21-7816-4fa9-9fc7-c559426ad2b9	2026-02-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200043 application number: ANDA200043
Armodafinil	ARMODAFINIL	Mylan Pharmaceuticals Inc.	de0799f7-7644-4057-a7da-75436f978c61	2018-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200043 application number: ANDA200043 ndc (product): 0378-3433 ndc (product): 0378-3431 ndc (product): 0378-3432

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-3431	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3431	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3432	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3432	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3433	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-3433	Armodafinil	armodafinil	Mylan Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31998	ORIG	2012-06-07