Changeflow GovPing Healthcare & Life Sciences Micro Labs Escitalopram Oxalate, 5/10/20mg, App...
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Micro Labs Escitalopram Oxalate, 5/10/20mg, Approved 22nd Apr

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Summary

The FDA approved ANDA 091655 for Micro Labs' Escitalopram Oxalate tablets in three strengths (5mg, 10mg, and 20mg base equivalents) as a prescription oral tablet formulation. The action on April 22, 2026 classified as ORIG-1 (Approval) with review priority of standard and no orphan status. The product carries TE Code AB (therapeutically equivalent) and is marketed as a prescription drug. Micro Labs joins 14 other approved generic escitalopram oxalate manufacturers listed by the FDA, with AbbVie's Lexapro (ANDA 021323) serving as the reference listed drug.

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What changed

FDA issued an Approval action for ANDA 091655 submitted by Micro Labs, authorizing the marketing of Escitalopram Oxalate tablets in three dosage strengths. The approval is classified as ORIG-1 under submission classification Not Applicable, with a standard review priority. The product maintains prescription status and holds TE Code AB designation for therapeutic equivalence.

Pharmaceutical manufacturers and healthcare providers should note that Micro Labs' entry into the generic escitalopram market adds to the existing competitive landscape of 14 other approved generic manufacturers. Generic drug purchasers and insurers may benefit from increased market competition for this commonly prescribed antidepressant. The AB therapeutic equivalence code confirms interchangeability with the reference listed drug Lexapro (AbbVie, ANDA 021323).

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Apr 24, 2026

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Abbreviated New Drug Application (ANDA): 091655
Company: MICRO LABS
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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
04/22/2026 ORIG-1 Approval Not Applicable 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 215177 ASCENT PHARMS INC
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 078169 CHARTWELL RX
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 078777 GRAVITI PHARMS
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 CADISTA
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 202210 MACLEODS PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 091655 MICRO LABS
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 090939 TORRENT PHARMS LTD
ESCITALOPRAM OXALATE ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription No AB 077734 ZYDUS LIFESCIENCES
LEXAPRO ESCITALOPRAM OXALATE EQ 5MG BASE TABLET;ORAL Prescription Yes AB 021323 ABBVIE

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

| 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 | 215177 | ASCENT PHARMS INC |
| 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 | 078169 | CHARTWELL RX |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 078777 | GRAVITI PHARMS |
| 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 CADISTA |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 202210 | MACLEODS PHARMS LTD |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 091655 | MICRO LABS |
| 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 | 090939 | TORRENT PHARMS LTD |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | No | AB | 077734 | ZYDUS LIFESCIENCES |
| LEXAPRO | ESCITALOPRAM OXALATE | EQ 10MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021323 | ABBVIE |
TABLET;ORAL; EQ 20MG BASE
TE Code = AB

| 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 | 215177 | ASCENT PHARMS INC |
| 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 | 078169 | CHARTWELL RX |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 078777 | GRAVITI PHARMS |
| 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 CADISTA |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 202210 | MACLEODS PHARMS LTD |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 091655 | MICRO LABS |
| 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 | 090939 | TORRENT PHARMS LTD |
| ESCITALOPRAM OXALATE | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | No | AB | 077734 | ZYDUS LIFESCIENCES |
| LEXAPRO | ESCITALOPRAM OXALATE | EQ 20MG BASE | TABLET;ORAL | Prescription | Yes | AB | 021323 | ABBVIE |

Mentioned entities

Food and Drug Administration

Parties

MICRO LABS

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FDA
Published
April 22nd, 2026
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Change scope
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3254 Pharmaceutical Manufacturing
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