Orange Book product · Generic (ANDA)
HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE
At a glance
Dec 16, 2025
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 16, 2025
6 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYZINE HYDROCHLORIDE
Strength
10MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 219648
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
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 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.
