Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 202221
Company: HETERO LABS LTD III
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 Yes
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/12/2012 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-6 Labeling-Package Insert

Label is not available on this site.

08/03/2021 SUPPL-5 Labeling-Package Insert

Label is not available on this site.

08/03/2021 SUPPL-4 Labeling-Package Insert

Label is not available on this site.

08/03/2021 SUPPL-2 Labeling-Package Insert

Label is not available on this site.

02/02/2016 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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