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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202227
Company: AMNEAL PHARMS
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
03/14/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202227s000ltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
12/10/2021 SUPPL-14 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/20/2021 SUPPL-12 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

09/03/2021 SUPPL-10 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/03/2021 SUPPL-6 Labeling-Medication Guide, Labeling-Package Insert

Label is not available on this site.

09/03/2021 SUPPL-5 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

05/14/2015 SUPPL-3 Labeling-Package Insert, Labeling-Medication Guide

Label is not available on this site.

12/10/2014 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

12/19/2013 SUPPL-1 Labeling-Package Insert

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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