Orange Book product · Brand (NDA)
LEXAPRO
ESCITALOPRAM OXALATE
At a glance
Nov 27, 2002
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 27, 2002
23 yr 11 mo ago
Exclusivity ends · NPP
New patient population exclusivity (3 years)
May 12, 2026
1 mo ago
Today
Pharmaceutical detail
Active ingredient
ESCITALOPRAM OXALATE
Strength
EQ 5MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
SOLUTION
Route
ORAL
TE code
Not listed
Application
NDA 021365
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2025ESCITALOPRAMBrand (NDA)
NDA 219130 · ALMATICA
- 2002LEXAPROBrand (NDA)
NDA 021323 · ABBVIE
- 2026ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 091655 · MICRO LABS
- 2025ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 215177 · ASCENT PHARMS INC
- 2017ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 205619 · AMNEAL PHARMS
- 2016ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 202754 · MACLEODS PHARMS LTD
- 2015ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 078032 · PRINSTON INC
- 2015ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 203967 · ANTRIM PHARMS LLC
- 2015ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 077550 · NOVITIUM PHARMA
- 2013ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 090477 · CHARTWELL MOLECULAR
- 2012ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 077512 · AIPING PHARM INC
- 2012ESCITALOPRAM OXALATEGeneric (ANDA)
ANDA 202280 · JUBILANT CADISTA
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
May 12, 2026
1 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
