FDA Orange Book · active-ingredient family
Alfuzosin hydrochloride
Alfuzosin 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:UROXATRAL · NDA 021287
1
Brand (NDA)
9
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| UROXATRALRLD | ADVANZ PHARMA | NDA 021287 | AB | Jun 12, 2003 |
Generic (ANDA) products (9)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALFUZOSIN HYDROCHLORIDE | UNICHEM | ANDA 203192 | AB | Jan 28, 2016 | |
| ALFUZOSIN HYDROCHLORIDE | AUROBINDO PHARMA LTD | ANDA 079060 | AB | Aug 30, 2012 | |
| ALFUZOSIN HYDROCHLORIDE | WOCKHARDT BIO AG | ANDA 090221 | — | Aug 10, 2012 | |
| ALFUZOSIN HYDROCHLORIDE | INVAGEN PHARMS | ANDA 090284 | AB | Jan 17, 2012 | |
| ALFUZOSIN HYDROCHLORIDE | APOTEX INC | ANDA 079013 | AB | Jul 18, 2011 | |
| ALFUZOSIN HYDROCHLORIDE | CHARTWELL RX | ANDA 079056 | — | Jul 18, 2011 | |
| ALFUZOSIN HYDROCHLORIDE | PHARMOBEDIENT | ANDA 079014 | — | Jul 18, 2011 | |
| ALFUZOSIN HYDROCHLORIDE | SUN PHARM | ANDA 079057 | — | Jul 18, 2011 | |
| ALFUZOSIN HYDROCHLORIDE | TORRENT PHARMS | ANDA 079054 | — | Jul 18, 2011 |
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.
Alfuzosin hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
