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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 040391
Company: PAI HOLDINGS PHARM

Products on ANDA 040391

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 040391

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/10/2002	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/40391ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/26/2024	SUPPL-11	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
11/08/2016	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
03/30/2016	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
06/03/2014	SUPPL-7	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040391Orig1s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/040391Orig1s007ltr.pdf

Labels for ANDA 040391

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/03/2014	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040391Orig1s007lbl.pdf

Therapeutic Equivalents for ANDA 040391

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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