Orange Book product · Brand (NDA)
IV PERSANTINE
DIPYRIDAMOLE
At a glance
Dec 13, 1990
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 13, 1990
36 yr ago
Today
Pharmaceutical detail
Active ingredient
DIPYRIDAMOLE
Strength
5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 019817
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 1986PERSANTINEBrand (NDA)
NDA 012836 · BOEHRINGER INGELHEIM
- 2008DIPYRIDAMOLEGeneric (ANDA)
ANDA 040898 · CHARTWELL RX
- 2008DIPYRIDAMOLEGeneric (ANDA)
ANDA 040874 · ZYDUS PHARMS USA INC
- 2007DIPYRIDAMOLEGeneric (ANDA)
ANDA 040782 · IMPAX LABS
- 2007DIPYRIDAMOLEGeneric (ANDA)
ANDA 040733 · RISING
- 2006DIPYRIDAMOLEGeneric (ANDA)
ANDA 040542 · OXFORD PHARMS
- 2002DIPYRIDAMOLEGeneric (ANDA)
ANDA 075769 · EUGIA PHARMA SPECLTS
- 1998DIPYRIDAMOLEGeneric (ANDA)
ANDA 074956 · FRESENIUS KABI USA
- 1998DIPYRIDAMOLEGeneric (ANDA)
ANDA 074939 · CHARTWELL INJECTABLE
- 1997DIPYRIDAMOLEGeneric (ANDA)
ANDA 074601 · HOSPIRA
- 1997DIPYRIDAMOLEGeneric (ANDA)
ANDA 074952 · DR REDDYS
- 1996DIPYRIDAMOLEGeneric (ANDA)
ANDA 074521 · HIKMA
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
