Orange Book product · Brand (NDA)
ATARAX
HYDROXYZINE HYDROCHLORIDE
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 HYDROCHLORIDE
Strength
10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 010392
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 011111 · PFIZER
- —ATARAXBrand (NDA)
NDA 010485 · ROERIG
- 2026HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 220271 · SAPTALIS PHARMS
- 2025HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219648 · NOVITIUM PHARMA
- 2025HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 219289 · BIONPHARMA
- 2023HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217652 · GRAVITI PHARMS
- 2019HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 210634 · APOZEAL PHARMS
- 2013HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 201674 · LANNETT CO INC
- 2008HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040808 · AMNEAL PHARM
- 2008HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040804 · CHARTWELL RX
- 2004HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040604 · EPIC PHARMA LLC
- 2004HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 040559 · ABLE
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.
