An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 202825
Company: ACCORD HLTHCARE

Products on ANDA 202825

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	AB	No	No
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	AB	No	No
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 202825

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/07/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/08/2018	SUPPL-2	Labeling-Package Insert		Label is not available on this site.
05/08/2018	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 202825

SERTRALINE HYDROCHLORIDE

TABLET;ORAL; EQ 25MG 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 25MG BASE	TABLET;ORAL	Prescription	No	AB	202825	ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076881	ACI
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	214790	ASCENT PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077206	AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078403	GRANULES
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076465	HERITAGE PHARMA AVET
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077397	INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	077670	LUPIN
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078175	OXFORD PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	078677	REYOUNG
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076442	SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	No	AB	076882	VIWIT PHARM
ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 25MG BASE	TABLET;ORAL	Prescription	Yes	AB	019839	VIATRIS

TABLET;ORAL; EQ 50MG 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 50MG BASE	TABLET;ORAL	Prescription	No	AB	202825	ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076881	ACI
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	214790	ASCENT PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077206	AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078403	GRANULES
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076465	HERITAGE PHARMA AVET
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077397	INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	077670	LUPIN
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078175	OXFORD PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	078677	REYOUNG
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076442	SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	No	AB	076882	VIWIT PHARM
ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 50MG BASE	TABLET;ORAL	Prescription	Yes	AB	019839	VIATRIS

TABLET;ORAL; EQ 100MG 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 100MG BASE	TABLET;ORAL	Prescription	No	AB	202825	ACCORD HLTHCARE
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076881	ACI
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	214790	ASCENT PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077206	AUROBINDO PHARMA
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078403	GRANULES
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076465	HERITAGE PHARMA AVET
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077397	INVAGEN PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	077670	LUPIN
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078175	OXFORD PHARMS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	078677	REYOUNG
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076442	SCIEGEN PHARMS INC
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	No	AB	076882	VIWIT PHARM
ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 100MG BASE	TABLET;ORAL	Prescription	Yes	AB	019839	VIATRIS

Top