Orange Book product · Brand (NDA)
VISTARIL
HYDROXYZINE PAMOATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
HYDROXYZINE PAMOATE
Strength
EQ 25MG HYDROCHLORIDE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 011795
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.
- —VISTARILBrand (NDA)
NDA 011459 · PFIZER
- 2013HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 201507 · HERITAGE PHARMA
- 1996HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 040156 · IMPAX LABS INC
- 1991HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 081165 · WATSON LABS
- 1991HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 081127 · BEXIMCO PHARMS USA
- 1991HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 081128 · SANDOZ
- 1991HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 081129 · SANDOZ
- 1987HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 089031 · SUPERPHARM
- 1987HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 089032 · SUPERPHARM
- 1987HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 089033 · SUPERPHARM
- 1986HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 089145 · PAR PHARM
- 1986HYDROXYZINE PAMOATEGeneric (ANDA)
ANDA 089146 · PAR PHARM
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.
