Orange Book product · Brand (NDA)
NIRAVAM
ALPRAZOLAM
At a glance
Jan 19, 2005
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 19, 2005
21 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
ALPRAZOLAM
Strength
0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
TE code
Not listed
Application
NDA 021726
Product number
001
Marketing status
DISCN
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.
- 2003XANAX XRBrand (NDA)
NDA 021434 · UPJOHN
- —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.
