FDA Orange Book · active-ingredient family
Dipyridamole
Dipyridamole is approved as 2 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:IV PERSANTINE · NDA 019817
2
Brand (NDA)
22
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| IV PERSANTINERLD | BOEHRINGER INGELHEIM | NDA 019817 | — | Dec 13, 1990 | |
| PERSANTINERLD×3 | BOEHRINGER INGELHEIM | NDA 012836 | — | Dec 22, 1986 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DIPYRIDAMOLE×3 | CHARTWELL RX | ANDA 040898 | — | Apr 23, 2008 | |
| DIPYRIDAMOLE×3 | ZYDUS PHARMS USA INC | ANDA 040874 | AB | Jan 28, 2008 | |
| DIPYRIDAMOLE×3 | IMPAX LABS | ANDA 040782 | AB | Jul 18, 2007 | |
| DIPYRIDAMOLE×3 | RISING | ANDA 040733 | AB | Feb 13, 2007 | |
| DIPYRIDAMOLE×3 | OXFORD PHARMS | ANDA 040542 | AB | Apr 21, 2006 | |
| DIPYRIDAMOLE | EUGIA PHARMA SPECLTS | ANDA 075769 | — | Nov 27, 2002 | |
| DIPYRIDAMOLE | FRESENIUS KABI USA | ANDA 074956 | — | Sep 30, 1998 | |
| DIPYRIDAMOLE | CHARTWELL INJECTABLE | ANDA 074939 | AP | Apr 13, 1998 | |
| DIPYRIDAMOLE | HOSPIRA | ANDA 074601 | — | Dec 19, 1997 | |
| DIPYRIDAMOLE | DR REDDYS | ANDA 074952 | — | Nov 26, 1997 | |
| DIPYRIDAMOLE | HIKMA | ANDA 074521 | AP | Oct 18, 1996 | |
| DIPYRIDAMOLE | WATSON LABS | ANDA 087160 | — | Jun 07, 1996 | |
| DIPYRIDAMOLE×3 | ANI PHARMS | ANDA 086944 | — | Apr 16, 1991 | |
| DIPYRIDAMOLE | GLENMARK GENERICS | ANDA 088999 | — | Feb 05, 1991 | |
| DIPYRIDAMOLE | GLENMARK GENERICS | ANDA 089000 | — | Feb 05, 1991 | |
| DIPYRIDAMOLE | GLENMARK GENERICS | ANDA 089001 | — | Feb 05, 1991 | |
| DIPYRIDAMOLE | BARR | ANDA 087184 | AB | Oct 03, 1990 | |
| DIPYRIDAMOLE | BARR | ANDA 087716 | AB | Oct 03, 1990 | |
| DIPYRIDAMOLE | BARR LABS | ANDA 087717 | AB | Oct 03, 1990 | |
| DIPYRIDAMOLE | PUREPAC PHARM | ANDA 089425 | — | Jul 12, 1990 | |
| DIPYRIDAMOLE | PUREPAC PHARM | ANDA 089426 | — | Jul 12, 1990 | |
| DIPYRIDAMOLE | PUREPAC PHARM | ANDA 089427 | — | Jul 12, 1990 |
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.
Dipyridamole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
