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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076465
Company: HERITAGE PHARMA AVET

Other Important Information from FDA

Products on ANDA 076465

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 076465

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/11/2006	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
03/28/2024	SUPPL-23	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
03/28/2024	SUPPL-20	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
02/21/2020	SUPPL-19	Labeling-Package Insert, Labeling-Medication Guide		Label is not available on this site.
05/21/2015	SUPPL-18	Labeling-Medication Guide, Labeling-Container/Carton Labels		Label is not available on this site.
11/28/2008	SUPPL-13	Labeling		Label is not available on this site.
07/16/2008	SUPPL-12	Labeling		Label is not available on this site.
06/11/2010	SUPPL-9	Labeling		Label is not available on this site.
01/11/2008	SUPPL-7	Labeling		Label is not available on this site.
01/11/2008	SUPPL-6	Labeling		Label is not available on this site.
03/28/2007	SUPPL-3	Labeling		Label is not available on this site.
03/28/2007	SUPPL-2	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076465

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

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