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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 219954
Company: ANNORA PHARMA

Products on ANDA 219954

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 219954

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 219954

PAROXETINE HYDROCHLORIDE

SUSPENSION;ORAL; EQ 10MG BASE/5ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION;ORAL	Prescription	No	AB	219954	ANNORA PHARMA
PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION;ORAL	Prescription	No	AB	215003	NOVITIUM PHARMA

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