Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 079121
Company: TARO
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;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
05/03/2012 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
09/21/2021 SUPPL-11 Labeling-Medication Guide, Labeling-Patient Package Insert, Labeling-Package Insert

Label is not available on this site.

09/08/2021 SUPPL-10 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/08/2021 SUPPL-9 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/08/2021 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

11/04/2014 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

05/20/2013 SUPPL-2 Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container/Carton Labels

Label is not available on this site.

05/20/2013 SUPPL-1 Labeling-Container/Carton Labels

Label is not available on this site.

ESCITALOPRAM OXALATE

SOLUTION;ORAL; EQ 5MG BASE/5ML
TE Code = AA

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202227 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 079062 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202221 HETERO LABS LTD III
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 090477 LANNETT CO INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 202754 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE/5ML SOLUTION;ORAL Prescription No AA 079121 TARO

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