Orange Book product · Generic (ANDA)
HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE
At a glance
Jan 10, 1986
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 10, 1986
41 yr ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYZINE HYDROCHLORIDE
Strength
25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 088618
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyGeneric (ANDA) of HYDROXYZINE HYDROCHLORIDE
- —VISTARILBrand (NDA)
NDA 011111 · PFIZER
- —ATARAXBrand (NDA)
NDA 010485 · ROERIG
- —ATARAXBrand (NDA)
NDA 010392 · PFIZER
- 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
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.
