Orange Book product · Brand (NDA)
XANAX
ALPRAZOLAM
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
ALPRAZOLAM
Strength
0.25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 018276
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
- 2003XANAX XRBrand (NDA)
NDA 021434 · 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.
