Orange Book product · Brand (NDA)

IHEEZO

CHLOROPROCAINE HYDROCHLORIDE

Brand (NDA)NDA 216227RX HARROW EYE

Sep 27, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Sep 27, 2022
3 yr 9 mo ago
Today
Patent 10792271 expires
Listed drug product patent expiration.
Sep 15, 2038
in 12 yr 5 mo
Patent 11969403 expires
Listed drug product patent expiration.
May 14, 2039
in 13 yr 1 mo

Active ingredient

CHLOROPROCAINE HYDROCHLORIDE

Strength

Dosage form

GEL

Route

OPHTHALMIC

TE code

Not listed

Application

NDA 216227

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
10792271	Sep 15, 2038	in 12 yr 5 mo	ProductU-3457
11969403	May 14, 2039	in 13 yr 1 mo	Product