Application 086944

Type: ANDA
Sponsor: ANI PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	50MG	No	No
002	DIPYRIDAMOLE	DIPYRIDAMOLE	TABLET;ORAL	25MG	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	Approval date
A086944-001	DIPYRIDAMOLE	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25
A086944-002	DIPYRIDAMOLE	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16
A086944-003	DIPYRIDAMOLE	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25

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	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086944-002	DIPYRIDAMOLE	25MG	TABLET / ORAL	1991-04-16	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086944-003	DIPYRIDAMOLE	75MG	TABLET / ORAL	1992-02-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086944-001	DIPYRIDAMOLE	50MG	TABLET / ORAL	1992-02-25	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086944-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086944-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086944-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086944-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086944-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A086944-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086944-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086944-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A086944-003	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A086944-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086944-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A086944-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086944-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086944-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A086944-003	AB	1	`782e0a99824c…`
2023-05-13 08:27 UTC	2023-05	A086944-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A086944-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A086944-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086944-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A086944-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A086944-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086944-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086944-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086944-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086944-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A086944-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A086944-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A086944-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A086944-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A086944-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086944-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086944-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A086944-003	AB	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dipyridamole	DIPYRIDAMOLE	Hikma Pharmaceuticals USA Inc.	6093dcd9-82d2-414f-8507-eda22c14f626	2026-05-20	Warnings, Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	REMEDYREPACK INC.	226099e2-70bb-4b9b-bb52-c20fbca2aec5	2026-04-29	Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Amneal Pharmaceuticals of New York LLC	a18b2af5-7c4a-4b7f-92c7-8a76e34da373	2026-04-15	Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Henry Schein, Inc.	1a2c0a9a-c637-4485-ad4b-0b6d0b05fa20	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
DIPYRIDAMOLE	DIPYRIDAMOLE	HF Acquisition Co LLC, DBA HealthFirst	9bd34108-9d98-c4ca-e053-2995a90a2bc8	2025-01-08	Warnings, Adverse reactions	Name fallback brand name: DIPYRIDAMOLE generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Zydus Lifesciences Limited	312aadb1-435c-4aa7-8e46-6506cedacaa0	2024-11-26		Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Zydus Pharmaceuticals USA Inc.	004bada0-dbf7-4a94-8792-6833d7eeda2b	2023-09-16	Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Oxford Pharmaceuticals, LLC	f7ffd78a-e93a-40f4-8193-2d6ab4dafd00	2021-03-29	Adverse reactions	Name fallback brand name: Dipyridamole generic name: DIPYRIDAMOLE

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
51407-626	Dipyridamole	Dipyridamole	Golden State Medical Supply, Inc.	ANDA	Current
51407-627	Dipyridamole	Dipyridamole	Golden State Medical Supply, Inc.	ANDA	Current
51407-628	Dipyridamole	Dipyridamole	Golden State Medical Supply, Inc.	ANDA	Current
62559-235	Dipyridamole	Dipyridamole	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-236	Dipyridamole	Dipyridamole	ANI Pharmaceuticals, Inc.	ANDA	Current
62559-237	Dipyridamole	Dipyridamole	ANI Pharmaceuticals, Inc.	ANDA	Current