FDA Orange Book · active-ingredient family
Alprazolam
Alprazolam is approved as 3 brand and 36 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NIRAVAM · NDA 021726
3
Brand (NDA)
36
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · concentrate, solution, tablet, tablet, extended release, tablet, orally disintegrating
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NIRAVAMRLD×4 | UCB INC | NDA 021726 | — | Jan 19, 2005 | |
| XANAX XRRLD×4 | UPJOHN | NDA 021434 | AB | Jan 17, 2003 | |
| XANAXRLD×4 | UPJOHN | NDA 018276 | AB | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (36)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ALPRAZOLAM×4 | CHARTWELL RX | ANDA 207507 | — | Jul 09, 2018 | |
| ALPRAZOLAM×4 | AUROBINDO PHARMA | ANDA 203346 | AB | Jul 31, 2015 | |
| ALPRAZOLAM×4 | NATCO | ANDA 200739 | AB | Apr 15, 2015 | |
| ALPRAZOLAM×4 | PH HEALTH | ANDA 078469 | — | Sep 29, 2011 | |
| ALPRAZOLAM×4 | AUROBINDO PHARMA | ANDA 090871 | AB | Jun 07, 2011 | |
| ALPRAZOLAM×4 | STRIDES PHARMA INTL | ANDA 090248 | — | Sep 17, 2010 | |
| ALPRAZOLAM×4 | SUN PHARM | ANDA 090082 | — | Jun 17, 2010 | |
| ALPRAZOLAM×4 | ACTAVIS LABS FL INC | ANDA 077198 | — | May 13, 2010 | |
| ALPRAZOLAM×4 | ACTAVIS ELIZABETH | ANDA 078561 | AB | Mar 16, 2010 | |
| ALPRAZOLAM×4 | PH HEALTH | ANDA 078088 | AB | Jan 09, 2009 | |
| ALPRAZOLAM×4 | APOTEX INC | ANDA 078449 | — | Nov 12, 2008 | |
| ALPRAZOLAM×4 | HERITAGE PHARMS INC | ANDA 078489 | — | Oct 17, 2008 | |
| ALPRAZOLAM×4 | OXFORD PHARMS | ANDA 078491 | — | Sep 25, 2008 | |
| ALPRAZOLAM×4 | AMNEAL PHARMS NY | ANDA 078387 | AB | May 30, 2008 | |
| ALPRAZOLAM×4 | PH HEALTH | ANDA 078442 | — | Oct 15, 2007 | |
| ALPRAZOLAM×4 | IMPAX LABS | ANDA 077968 | — | May 24, 2007 | |
| ALPRAZOLAM×4 | ANI PHARMS | ANDA 077979 | — | Feb 28, 2007 | |
| ALPRAZOLAM×4 | ACTAVIS ELIZABETH | ANDA 078056 | AB | Feb 13, 2007 | |
| ALPRAZOLAM×4 | IMPAX LABS INC | ANDA 077996 | — | Jan 31, 2007 | |
| ALPRAZOLAM×4 | APOTEX INC | ANDA 077741 | — | Jan 19, 2007 | |
| ALPRAZOLAM×4 | ANI PHARMS | ANDA 077725 | — | Jul 31, 2006 | |
| ALPRAZOLAM×4 | SANDOZ INC | ANDA 077777 | — | Jun 30, 2006 | |
| ALPRAZOLAM×4 | PHARMOBEDIENT | ANDA 077391 | — | Jan 26, 2006 | |
| ALPRAZOLAM | SANDOZ | ANDA 074909 | AB | Mar 25, 1998 | |
| ALPRAZOLAM×3 | WATSON LABS | ANDA 074479 | — | Jan 21, 1997 | |
| ALPRAZOLAM×3 | SANDOZ | ANDA 074112 | AB | Dec 29, 1995 | |
| ALPRAZOLAM×3 | WATSON LABS | ANDA 074456 | — | Aug 31, 1995 | |
| ALPRAZOLAM×4 | IVAX SUB TEVA PHARMS | ANDA 074294 | — | Jul 29, 1994 | |
| ALPRAZOLAM×4 | ANI PHARMS | ANDA 074085 | — | Feb 16, 1994 | |
| ALPRAZOLAM×4 | MYLAN | ANDA 074215 | — | Jan 27, 1994 | |
| ALPRAZOLAM | HIKMA | ANDA 074312 | — | Oct 31, 1993 | |
| ALPRAZOLAM | ROXANE | ANDA 074314 | — | Oct 31, 1993 | |
| ALPRAZOLAM×4 | ACTAVIS ELIZABETH | ANDA 074342 | AB | Oct 31, 1993 | |
| ALPRAZOLAM×4 | NOVITIUM PHARMA | ANDA 074174 | AB | Oct 19, 1993 | |
| ALPRAZOLAM×4 | PHARMOBEDIENT | ANDA 074046 | — | Oct 19, 1993 | |
| ALPRAZOLAM×3 | ROXANE | ANDA 074199 | — | Oct 19, 1993 |
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.
Alprazolam — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
