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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219648
Company: NOVITIUM PHARMA

Products on ANDA 219648

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219648

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/16/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219648

HYDROXYZINE HYDROCHLORIDE

SYRUP;ORAL; 10MG/5ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	210634	APOZEAL PHARMS
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	219289	BIONPHARMA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	Yes	AA	087294	CHARTWELL RX
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	201674	LANNETT CO INC
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	219648	NOVITIUM PHARMA
HYDROXYZINE HYDROCHLORIDE	HYDROXYZINE HYDROCHLORIDE	10MG/5ML	SYRUP;ORAL	Prescription	No	AA	040391	PAI HOLDINGS PHARM

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