Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078777
Company: RISING
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription AB No No
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription AB No No
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription AB 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
09/11/2012 ORIG-1 Approval Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/078777s000TAltr.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
01/22/2016 SUPPL-3 Labeling-Package Insert

Label is not available on this site.

01/22/2016 SUPPL-1 Labeling-Package Insert

Label is not available on this site.

ESCITALOPRAM OXALATE

TABLET;ORAL; EQ 5MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077734 CADILA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077512 PHARM ASSOC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078777 RISING
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 021323 ALLERGAN

TABLET;ORAL; EQ 10MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077734 CADILA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 077512 PHARM ASSOC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 078777 RISING
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
LEXAPRO ESCITALOPRAM OXALATE EQ 10MG BASE TABLET;ORAL Prescription Yes AB 021323 ALLERGAN

TABLET;ORAL; EQ 20MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 202389 ACCORD HLTHCARE
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 205619 AMNEAL PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 090432 AUROBINDO PHARMA LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 077734 CADILA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078604 INVAGEN PHARMS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 202280 JUBILANT GENERICS
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078169 LUPIN LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 077512 PHARM ASSOC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078032 PRINSTON INC
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 078777 RISING
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 076765 TEVA PHARMS USA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription No AB 090939 TORRENT PHARMS LTD
LEXAPRO ESCITALOPRAM OXALATE EQ 20MG BASE TABLET;ORAL Prescription Yes AB 021323 ALLERGAN

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