Application 216227

Type: NDA
Sponsor: SINTETICA SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IHEEZO	CHLOROPROCAINE HYDROCHLORIDE	GEL;OPHTHALMIC	3%	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N216227-001	IHEEZO	CHLOROPROCAINE HYDROCHLORIDE	3%	GEL / OPHTHALMIC		RLD, RS	2022-09-27

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26
N216227-001	11969403	2039-05-14		Drug product	2025-02-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC		RLD, RS	2022-09-27	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
IHEEZO	CHLOROPROCAINE HYDROCHLORIDE OPHTHALMIC GEL	Harrow Eye, LLC	ea3b2d2c-8b33-d199-e053-2995a90a699c	2026-03-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 216227 application number: NDA216227 ndc (product): 82667-300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 1 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
82667-300	IHEEZO	chloroprocaine hydrochloride ophthalmic gel	Harrow Eye, LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74919	ORIG	2023-07-28
72173	ORIG	2022-09-28
72172	ORIG	2022-09-28