Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076934
Company: ACI

• Other Important Information from FDA

Products on ANDA 076934

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 076934

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/30/2006	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76934APltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/05/2019	SUPPL-7	Labeling-Package Insert		Label is not available on this site.
11/19/2015	SUPPL-6	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
07/16/2008	SUPPL-5	Labeling		Label is not available on this site.
01/09/2008	SUPPL-4	Labeling		Label is not available on this site.
01/09/2008	SUPPL-3	Labeling		Label is not available on this site.

Therapeutic Equivalents for ANDA 076934

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