Drugs@FDA: FDA Approved Drug Products

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Abbreviated New Drug Application (ANDA): 078861
Company: AUROBINDO PHARMA
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
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
01/31/2019 SUPPL-16 Labeling-Package Insert, Labeling-Container/Carton Labels

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.

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 078861 AUROBINDO PHARMA
ZOLOFT SERTRALINE HYDROCHLORIDE EQ 20MG BASE/ML CONCENTRATE;ORAL Prescription Yes AA 020990 PFIZER

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