Application 074952

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIPYRIDAMOLE	DIPYRIDAMOLE	INJECTABLE;INJECTION	5MG/ML	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A074952-001	DIPYRIDAMOLE	DIPYRIDAMOLE	5MG/ML	INJECTABLE / INJECTION			1997-11-26

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	A074952-001	DIPYRIDAMOLE	5MG/ML	INJECTABLE / INJECTION	1997-11-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A074952-001	DIPYRIDAMOLE	5MG/ML	INJECTABLE / INJECTION	1997-11-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A074952-001	DIPYRIDAMOLE	5MG/ML	INJECTABLE / INJECTION	1997-11-26	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A074952-001	DIPYRIDAMOLE	5MG/ML	INJECTABLE / INJECTION	1997-11-26	`a50c72e98297…`

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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.