Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 076934
Company: ACI HEALTHCARE LTD
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
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.

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 HEALTHCARE LTD
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 UPJOHN

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