FDA.reportPublic FDA data

Application 012583

Type
NDA
Sponsor
ALLERGAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001OPHTHETICPROPARACAINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N012583-001OPHTHETICPROPARACAINE HYDROCHLORIDE0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N012583-001OPHTHETIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012583-001OPHTHETIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012583-001OPHTHETIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012583-001OPHTHETIC0.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**SOLUTION/DROPS / OPHTHALMICRLD, Approved before 1982a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AlcainePROPARACAINE HYDROCHLORIDEAlcon Laboratories, Inc.0c0fa0bf-977d-4539-b8dc-54c187c5b0942026-06-10Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDESportpharm LLC1d257859-cd1d-485f-a4d5-dbb33c1ec1972026-04-24Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDESportpharm LLC509fed7b-637b-418c-93cd-19f49ba8740c2026-04-24Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDEREMEDYREPACK INC.55ed1359-d95c-4c2b-ad5a-cc8e023c43312026-04-09Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDESportpharm LLC4ae89863-233f-4015-92da-aad0f2a876772026-02-06Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloridePROPARACAINE HYDROCHLORIDEMicro Labs Limiteddf1af0e8-7d9d-4511-9d86-f0c31a5da2c22025-10-22Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine hydrochloridePROPARACAINE HYDROCHLORIDELifestar Pharma LLC3419104b-e847-492f-a541-a810a116c4082025-05-23Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
proparacaine hydrochloridePROPARACAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.9a67a989-ec6b-4a26-e053-2a95a90a826d2025-01-02Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDESomerset Therapeutics, LLC968a6e4e-814f-41f8-ae22-aa5a82179a6c2024-08-14Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.68a84d3f-a8f8-13ee-e053-2991aa0a75922024-06-07Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDEA-S Medication Solutions7a4fa88b-a3e1-479e-8bd9-4c5bc4dbf2612023-12-10Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDEBausch & Lomb Incorporatedb699f838-8b69-4bac-953b-ea8822ec19fc2023-09-01Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE
Proparacaine HydrochloridePROPARACAINE HYDROCHLORIDESandoz Inc.447a2a64-0507-4fe8-bb44-cc36c39161512022-06-29Warnings, Adverse reactionsName fallback
generic name: PROPARACAINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
33087SUPPL2002-06-20
12021SUPPL2002-06-20
10815SUPPL2002-06-20
336SUPPL2002-06-20