Orange Book product · Brand (NDA)
UROXATRAL
ALFUZOSIN HYDROCHLORIDE
At a glance
Jun 12, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 12, 2003
23 yr 4 mo ago
Today
Pharmaceutical detail
Active ingredient
ALFUZOSIN HYDROCHLORIDE
Strength
10MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021287
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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.
- 2016ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 203192 · UNICHEM
- 2012ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079060 · AUROBINDO PHARMA LTD
- 2012ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090221 · WOCKHARDT BIO AG
- 2012ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 090284 · INVAGEN PHARMS
- 2011ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079013 · APOTEX INC
- 2011ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079056 · CHARTWELL RX
- 2011ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079014 · PHARMOBEDIENT
- 2011ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079057 · SUN PHARM
- 2011ALFUZOSIN HYDROCHLORIDEGeneric (ANDA)
ANDA 079054 · TORRENT PHARMS
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.
