FDA.reportPublic FDA data

Application 040277

Type
ANDA
Sponsor
AKORN INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDESOLUTION/DROPS;OPHTHALMIC0.5%NoYes

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
A040277-001PROPARACAINE HYDROCHLORIDEPROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A040277-001AT

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 UTC2022-10A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICATRS2000-03-16cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040277-001PROPARACAINE HYDROCHLORIDE0.5%SOLUTION/DROPS / OPHTHALMICAT2000-03-16a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A040277-001AT1c2088c7a36db…
2026-09-14 22:38:342026-08A040277-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A040277-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040277-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040277-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040277-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040277-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040277-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040277-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040277-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040277-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040277-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040277-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040277-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040277-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040277-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040277-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040277-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040277-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040277-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040277-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040277-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040277-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040277-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A040277-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040277-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040277-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040277-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A040277-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040277-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040277-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040277-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040277-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040277-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040277-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040277-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040277-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040277-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040277-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040277-001AT13a93d1ddd44b…

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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
0404-7199Proparacaine HydrochlorideProparacaine HydrochlorideHenry Schein Inc.ANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
13985-611Proparacaine HydrochlorideProparacaine HydrochlorideMWIANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkornANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkornANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkorn, Inc.ANDACurrent
17478-263Proparacaine HydrochlorideProparacaine HydrochlorideAkorn, Inc.ANDACurrent
50090-0259Proparacaine HydrochlorideProparacaine HydrochlorideA-S Medication SolutionsANDACurrent
70518-2056Proparacaine HydrochlorideProparacaine HydrochlorideREMEDYREPACK INC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
17762ORIG2004-06-14
22112ORIG2003-07-31
7601ORIG2000-03-16