LEXAPRO — FDA application NDA021323

Application NDA021323 · type NDA · FDA status: approved · original approval 2002-08-14

Listed sponsor: ABBVIE · ABBV company profile · exact_unique

Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.

FDA application facts

Product	FDA-listed trade name	Active ingredient	Dosage form	Route	Strength	Marketing status	TE code	RLD
001	LEXAPRO	ESCITALOPRAM OXALATE	TABLET	ORAL	EQ 5MG BASE	Prescription	AB	Yes
002	LEXAPRO	ESCITALOPRAM OXALATE	TABLET	ORAL	EQ 10MG BASE	Prescription	AB	Yes
003	LEXAPRO	ESCITALOPRAM OXALATE	TABLET	ORAL	EQ 20MG BASE	Prescription	AB	Yes

Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.

Listing	Product	Descriptive date	Flags/code
Exclusivity NPP	001	listed exclusivity date: 2026-05-12	FDA code as listed
Exclusivity NPP	002	listed exclusivity date: 2026-05-12	FDA code as listed
Exclusivity NPP	003	listed exclusivity date: 2026-05-12	FDA code as listed

Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.

ESCITALOPRAM OXALATE · UNII 5U85DBW7LO · lmmol compound KTGRHKOEFSJQNS-BDQAORGHSA-N · CHEMBL1200322

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.