Orange Book product · Generic (ANDA)
HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE
At a glance
Apr 12, 1982
Approved
Generic (ANDA)
Application
AA
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 12, 1982
44 yr 10 mo ago
Today
Pharmaceutical detail
Active ingredient
HYDROXYZINE HYDROCHLORIDE
Strength
10MG/5ML
Dosage form
SYRUP
Route
ORAL
TE code
AA
Application
ANDA 087294
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
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ANDA 219648 · NOVITIUM PHARMA
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ANDA 219289 · BIONPHARMA
- 2023HYDROXYZINE HYDROCHLORIDEGeneric (ANDA)
ANDA 217652 · GRAVITI PHARMS
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ANDA 210634 · APOZEAL PHARMS
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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.
