Application 008883

Type: NDA
Sponsor: APOTHECON

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OPHTHAINE	PROPARACAINE HYDROCHLORIDE	SOLUTION/DROPS;OPHTHALMIC	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N008883-001	OPHTHAINE	PROPARACAINE HYDROCHLORIDE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC		RLD, Approved before 1982

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N008883-001	OPHTHAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N008883-001	OPHTHAINE	0.5%	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N008883-001	OPHTHAINE	0.5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION/DROPS / OPHTHALMIC	RLD, Approved before 1982	`f41ea6bd6efb…`

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alcaine	PROPARACAINE HYDROCHLORIDE	Alcon Laboratories, Inc.	0c0fa0bf-977d-4539-b8dc-54c187c5b094	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	1d257859-cd1d-485f-a4d5-dbb33c1ec197	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	509fed7b-637b-418c-93cd-19f49ba8740c	2026-04-24	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	REMEDYREPACK INC.	55ed1359-d95c-4c2b-ad5a-cc8e023c4331	2026-04-09	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sportpharm LLC	4ae89863-233f-4015-92da-aad0f2a87677	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	Micro Labs Limited	df1af0e8-7d9d-4511-9d86-f0c31a5da2c2	2025-10-22	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	Lifestar Pharma LLC	3419104b-e847-492f-a541-a810a116c408	2025-05-23	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
proparacaine hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	9a67a989-ec6b-4a26-e053-2a95a90a826d	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Somerset Therapeutics, LLC	968a6e4e-814f-41f8-ae22-aa5a82179a6c	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	NuCare Pharmaceuticals,Inc.	68a84d3f-a8f8-13ee-e053-2991aa0a7592	2024-06-07	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	A-S Medication Solutions	7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf261	2023-12-10	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Bausch & Lomb Incorporated	b699f838-8b69-4bac-953b-ea8822ec19fc	2023-09-01	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine Hydrochloride	PROPARACAINE HYDROCHLORIDE	Sandoz Inc.	447a2a64-0507-4fe8-bb44-cc36c3916151	2022-06-29	Warnings, Adverse reactions	Name fallback generic name: PROPARACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.