FDA Orange Book · active-ingredient family
Anagrelide hydrochloride
Anagrelide hydrochloride is approved as 1 brand and 9 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:AGRYLIN · NDA 020333
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AGRYLINRLD×2 | TAKEDA PHARMS USA | NDA 020333 | — | Mar 14, 1997 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ANAGRELIDE HYDROCHLORIDE×2 | TORRENT | ANDA 209151 | AB | Jun 30, 2017 | |
| ANAGRELIDE HYDROCHLORIDE×2 | RISING | ANDA 077613 | — | Jun 27, 2006 | |
| ANAGRELIDE HYDROCHLORIDE×2 | BARR LABS | ANDA 076530 | — | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | CHARTWELL RX | ANDA 076683 | — | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | CIPLA | ANDA 076468 | AB | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | IMPAX LABS | ANDA 076910 | AB | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | NOVITIUM PHARMA | ANDA 076811 | AB | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | ROXANE | ANDA 076489 | — | Apr 18, 2005 | |
| ANAGRELIDE HYDROCHLORIDE×2 | WATSON LABS | ANDA 076417 | — | Apr 18, 2005 |
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.
Anagrelide hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
