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 42.

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N216227-001	IHEEZO	3%	GEL / OPHTHALMIC	RLD, RS	2022-09-27	`f41ea6bd6efb…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	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
2026-08-18 06:07:40	2026-07	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`3a93d1ddd44b…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216227-001	10792271	2038-09-15	U-3457	Drug product	2022-10-26	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N216227-001	11969403	2039-05-14		Drug product	2025-02-07	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N216227-001	NP	2025-09-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N216227-001	NP	2025-09-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N216227-001	NP	2025-09-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N216227-001	NP	2025-09-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N216227-001	NP	2025-09-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N216227-001	NP	2025-09-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N216227-001	NP	2025-09-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N216227-001	NP	2025-09-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N216227-001	NP	2025-09-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N216227-001	NP	2025-09-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N216227-001	NP	2025-09-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N216227-001	NP	2025-09-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N216227-001	NP	2025-09-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N216227-001	NP	2025-09-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N216227-001	NP	2025-09-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N216227-001	NP	2025-09-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N216227-001	NP	2025-09-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N216227-001	NP	2025-09-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N216227-001	NP	2025-09-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N216227-001	NP	2025-09-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N216227-001	NP	2025-09-27	`053a50430f4f…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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