Application 040542

Type: ANDA
Sponsor: OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	25MG	No	No
002	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	50MG	No	No
003	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	75MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A040542-001	DIPYRIDAMOLE	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21
A040542-002	DIPYRIDAMOLE	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21
A040542-003	DIPYRIDAMOLE	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040542-001	AB
A040542-002	AB
A040542-003	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 4 · 126 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	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-002	DIPYRIDAMOLE	50MG	TABLET / ORAL	AB	2006-04-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	AB	2006-04-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040542-001	DIPYRIDAMOLE	25MG	TABLET / ORAL	AB	2006-04-21	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 108 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	A040542-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040542-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040542-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040542-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040542-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040542-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040542-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040542-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040542-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040542-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040542-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040542-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040542-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040542-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040542-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040542-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040542-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040542-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040542-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040542-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040542-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040542-001	AB	1	`1e350fbaab3a…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dipyridamole	DIPYRIDAMOLE	Oxford Pharmaceuticals, LLC	f7ffd78a-e93a-40f4-8193-2d6ab4dafd00	2021-03-29	Adverse reactions	Exact identifier application applno (ANDA): 040542 application number: ANDA040542 ndc (product): 69584-181 ndc (product): 69584-183 ndc (product): 69584-182

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69584-181	Dipyridamole	Dipyridamole	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-182	Dipyridamole	Dipyridamole	Oxford Pharmaceuticals, LLC	ANDA	Current
69584-183	Dipyridamole	Dipyridamole	Oxford Pharmaceuticals, LLC	ANDA	Current