Orange Book product · Brand (NDA)
XANAX XR
ALPRAZOLAM
At a glance
Jan 17, 2003
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 17, 2003
23 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ALPRAZOLAM
Strength
0.5MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
AB
Application
NDA 021434
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
- 2005NIRAVAMBrand (NDA)
NDA 021726 · UCB INC
- —XANAXBrand (NDA)
NDA 018276 · UPJOHN
- 2018ALPRAZOLAMGeneric (ANDA)
ANDA 207507 · CHARTWELL RX
- 2015ALPRAZOLAMGeneric (ANDA)
ANDA 203346 · AUROBINDO PHARMA
- 2015ALPRAZOLAMGeneric (ANDA)
ANDA 200739 · NATCO
- 2011ALPRAZOLAMGeneric (ANDA)
ANDA 078469 · PH HEALTH
- 2011ALPRAZOLAMGeneric (ANDA)
ANDA 090871 · AUROBINDO PHARMA
- 2010ALPRAZOLAMGeneric (ANDA)
ANDA 090248 · STRIDES PHARMA INTL
- 2010ALPRAZOLAMGeneric (ANDA)
ANDA 090082 · SUN PHARM
- 2010ALPRAZOLAMGeneric (ANDA)
ANDA 077198 · ACTAVIS LABS FL INC
- 2010ALPRAZOLAMGeneric (ANDA)
ANDA 078561 · ACTAVIS ELIZABETH
- 2009ALPRAZOLAMGeneric (ANDA)
ANDA 078088 · PH HEALTH
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.
