Application 012836

Type: NDA
Sponsor: BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
003	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	25MG	Yes	No
004	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	50MG	Yes	No
005	PERSANTINE	DIPYRIDAMOLE	TABLET;ORAL	75MG	Yes	Yes

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	RLD / RS	Approval date
N012836-003	PERSANTINE	DIPYRIDAMOLE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-12-22
N012836-004	PERSANTINE	DIPYRIDAMOLE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06
N012836-005	PERSANTINE	DIPYRIDAMOLE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N012836-003	PERSANTINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-12-22	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012836-004	PERSANTINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N012836-005	PERSANTINE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N012836-003	PERSANTINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012836-004	PERSANTINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N012836-005	PERSANTINE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012836-003	PERSANTINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012836-004	PERSANTINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N012836-005	PERSANTINE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N012836-003	PERSANTINE	25MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1986-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012836-004	PERSANTINE	50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N012836-005	PERSANTINE	75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1987-02-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012836-004	PERSANTINE	50MG	TABLET / ORAL	RLD	1987-02-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N012836-005	PERSANTINE	75MG	TABLET / ORAL	RLD	1987-02-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N012836-003	PERSANTINE	25MG	TABLET / ORAL	RLD	1986-12-22	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-05-31 18:47 UTC	2024-05	N012836-003	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012836-004	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N012836-005	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012836-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012836-004	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N012836-005	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N012836-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012836-004	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N012836-005	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N012836-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012836-004	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N012836-005	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N012836-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012836-004	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N012836-005	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N012836-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012836-004	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N012836-005	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N012836-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012836-004	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N012836-005	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012836-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012836-004	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N012836-005	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N012836-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012836-004	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N012836-005	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N012836-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012836-004	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N012836-005	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N012836-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012836-004	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N012836-005	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N012836-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012836-004	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N012836-005	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N012836-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012836-004	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N012836-005	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N012836-003	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 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 generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	REMEDYREPACK INC.	226099e2-70bb-4b9b-bb52-c20fbca2aec5	2026-04-29	Adverse reactions	Name fallback generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Amneal Pharmaceuticals of New York LLC	a18b2af5-7c4a-4b7f-92c7-8a76e34da373	2026-04-15	Adverse reactions	Name fallback generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Henry Schein, Inc.	1a2c0a9a-c637-4485-ad4b-0b6d0b05fa20	2025-10-30	Warnings, Adverse reactions	Name fallback generic name: DIPYRIDAMOLE
DIPYRIDAMOLE	DIPYRIDAMOLE	HF Acquisition Co LLC, DBA HealthFirst	9bd34108-9d98-c4ca-e053-2995a90a2bc8	2025-01-08	Warnings, Adverse reactions	Name fallback generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Zydus Lifesciences Limited	312aadb1-435c-4aa7-8e46-6506cedacaa0	2024-11-26		Name fallback generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Zydus Pharmaceuticals USA Inc.	004bada0-dbf7-4a94-8792-6833d7eeda2b	2023-09-16	Adverse reactions	Name fallback generic name: DIPYRIDAMOLE
Dipyridamole	DIPYRIDAMOLE	Oxford Pharmaceuticals, LLC	f7ffd78a-e93a-40f4-8193-2d6ab4dafd00	2021-03-29	Adverse reactions	Name fallback generic name: DIPYRIDAMOLE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0597-0017	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0017	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0018	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0018	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0019	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
0597-0019	Persantine	dipyridamole	Boehringer Ingelheim Pharmaceuticals, Inc.	NDA	Current
68151-2996	Dipyridamole	Dipyridamole	Carilion Materials Management	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
61247	SUPPL	2019-12-12
61246	SUPPL	2019-12-12
33096	SUPPL	2005-08-03
345	SUPPL	2005-08-03
12038	SUPPL	2004-08-06