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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218342
Company: UMEDICA

Products on ANDA 218342

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	AB	No	No
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218342

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/20/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218342

SERTRALINE HYDROCHLORIDE

CAPSULE;ORAL; EQ 150MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	215133	ALMATICA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218712	APPCO
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	219714	NOVITIUM PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	219655	SKG PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218342	UMEDICA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	218853	ZENARA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 150MG BASE	CAPSULE;ORAL	Prescription	No	AB	220275	ZYDUS LIFESCIENCES

CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	Yes	AB	215133	ALMATICA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218712	APPCO
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	219714	NOVITIUM PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	219655	SKG PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218342	UMEDICA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	218853	ZENARA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 200MG BASE	CAPSULE;ORAL	Prescription	No	AB	220275	ZYDUS LIFESCIENCES

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