FDA Orange Book · active-ingredient family
Aspirin; dipyridamole
Aspirin; dipyridamole is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AGGRENOX · NDA 020884
1
Brand (NDA)
11
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AGGRENOXRLD | BOEHRINGER INGELHEIM | NDA 020884 | — | Nov 22, 1999 |
Generic (ANDA) products (11)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ASPIRIN AND DIPYRIDAMOLE | MICRO LABS | ANDA 209929 | AB | Aug 11, 2021 | |
| ASPIRIN AND DIPYRIDAMOLE | GLENMARK SPECLT | ANDA 210318 | AB | May 24, 2019 | |
| ASPIRIN AND DIPYRIDAMOLE | CHARTWELL MOLECULAR | ANDA 204552 | — | Mar 20, 2019 | |
| ASPIRIN AND DIPYRIDAMOLE | DR REDDYS | ANDA 209048 | AB | Oct 10, 2018 | |
| ASPIRIN AND DIPYRIDAMOLE | SUN PHARM | ANDA 208572 | — | Aug 21, 2018 | |
| ASPIRIN AND DIPYRIDAMOLE | ZYDUS PHARMS | ANDA 206753 | AB | Aug 29, 2017 | |
| ASPIRIN AND DIPYRIDAMOLE | ANI PHARMS | ANDA 206964 | — | Jan 18, 2017 | |
| ASPIRIN AND DIPYRIDAMOLE | PH HEALTH | ANDA 207944 | AB | Jan 18, 2017 | |
| ASPIRIN AND DIPYRIDAMOLE | SANDOZ | ANDA 206739 | AB | Jan 18, 2017 | |
| ASPIRIN AND DIPYRIDAMOLE | AMNEAL PHARMS | ANDA 206392 | AB | Mar 08, 2016 | |
| ASPIRIN AND DIPYRIDAMOLE | BARR | ANDA 078804 | AB | Aug 14, 2009 |
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.
Aspirin; dipyridamole — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
