Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078861
Company: AUROBINDO PHARMA

• Other Important Information from FDA

Products on ANDA 078861

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078861

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/31/2008	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
02/02/2024	SUPPL-26	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/08/2023	SUPPL-23	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/08/2023	SUPPL-21	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
01/31/2019	SUPPL-16	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.
01/31/2019	SUPPL-15	Labeling-Package Insert		Label is not available on this site.
08/03/2017	SUPPL-13	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
08/03/2017	SUPPL-5	Labeling-Container/Carton Labels		Label is not available on this site.
01/29/2013	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
02/25/2009	SUPPL-1	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 078861

SERTRALINE HYDROCHLORIDE

CONCENTRATE;ORAL; EQ 20MG BASE/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE;ORAL	Prescription	No	AA	076934	ACI
SERTRALINE HYDROCHLORIDE	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE;ORAL	Prescription	No	AA	078861	AUROBINDO PHARMA
ZOLOFT	SERTRALINE HYDROCHLORIDE	EQ 20MG BASE/ML	CONCENTRATE;ORAL	Prescription	Yes	AA	020990	VIATRIS