Home Applications 080429 Application 080429
Type ANDA
Sponsor BIONPHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ANESTACON LIDOCAINE HYDROCHLORIDE JELLY;TOPICAL 2% No 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 A080429-001 ANESTACON LIDOCAINE HYDROCHLORIDE 2% JELLY / TOPICAL 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 Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 84e616aacf4f…2026-08-18 06:07:40 2026-07 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A080429-001 ANESTACON 2% JELLY / TOPICAL Approved before 1982 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A080429-001 ANESTACON 2% JELLY / TOPICAL 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 12 of 16 · 302 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Xylocaine MPF LIDOCAINE HYDROCHLORIDE Fresenius Kabi USA, LLC fe265eb5-eaeb-4f47-82dd-238c1d53fec4 2024-03-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE SunBurnt PLUS LIDOCAINE HYDROCHLORIDE Quest Products, LLC. 12128c75-015d-8a72-e063-6394a90ae00a 2024-02-23 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Kroger Analgesic Analgesic LIDOCAINE HYDROCHLORIDE THE KROGER CO e6c5ead3-87d0-48ed-a4dc-86cf89ebb285 2024-02-22 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE NuCare Pharmaceuticals,Inc. 0050d05a-b8e9-c544-e063-6294a90a0243 2024-02-08 Boxed warning, Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 1c5eb3b3-79b3-472a-ae36-ec6a7dc72925 2024-02-07 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Safetec of America, Inc. 8eb3e7e2-26e5-430e-89aa-40a0367c637e 2024-02-07 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c4bf5905-add7-1cb0-e053-2995a90a7334 2024-01-30 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE LIDOCAINE HYDROCHLORIDE HF Acquisition Co LLC, DBA HealthFirst c4c0df51-cc37-323d-e053-2995a90a154a 2024-01-30 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Seton Pharmaceuticals 1c0abe84-5404-404e-b882-e910e4d43ffb 2024-01-30 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Burn LIDOCAINE HYDROCHLORIDE Nantong Health & Beyond Hygienic Products Inc. eca272cb-ac8f-982b-e053-2995a90aa8b2 2024-01-15 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Caring mill Lidocaine Aloe Gel Burn and Pain Relief LIDOCAINE HYDROCHLORIDE FSA Store Inc. 0ec20c87-1681-dd23-e063-6394a90a291c 2024-01-12 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Golden State Medical Supply, Inc. 09c10cd0-b634-ab9d-e063-6294a90aa544 2024-01-09 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Theraworx Pain Relief Roll-On with Lidocaine for Diabetics LIDOCAINE HYDROCHLORIDE AVADIM HOLDINGS, INC. e07f5bf7-5a9a-468c-8c3f-2c6f0b17af29 2024-01-08 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE equate Maximum Strength Pain Relieving 4% Lidocaine with Lavender Essential Oil Topical analgesic LIDOCAINE HYDROCHLORIDE Wal-Mart Stores, Inc. bf954949-a7b7-44ba-8565-f1d5c0a6c0d1 2023-12-21 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Hikma Pharmaceuticals USA Inc. c5d27da0-e495-4bb6-a7e1-8eaa6595eb71 2023-12-14 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE Thera Plus Max Strength Lidocaine Pain Relief Liquid LIDOCAINE HYDROCHLORIDE Fourstar Group USA, Inc. 0a228b06-0e1c-6c75-e063-6294a90a9a0e 2023-11-30 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Southern Sales & Service, Inc. 9089cb78-e9f8-4437-a767-df809a114c4b 2023-11-29 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Medical Purchasing Solutions, LLC 0a353fe1-b779-3d1f-e063-6294a90ab21b 2023-11-15 Warnings, Adverse reactions Name fallback generic name: LIDOCAINE HYDROCHLORIDE MAXOCAINE Lidocaine Hemp Oil Topical Analgesic LIDOCAINE HYDROCHLORIDE Prime Commerce, LLC 28ed2149-38d2-4062-8442-990a98a69cfc 2023-11-11 Warnings Name fallback generic name: LIDOCAINE HYDROCHLORIDE SUGAR BRANDS Rescue Pain Relief and Recovery LIDOCAINE HYDROCHLORIDE Sugar Brands, LLC 74013709-d1d5-4425-825d-eee726718c61 2023-11-11 Warnings Name fallback generic name: LIDOCAINE 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 · 1 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50383-772 Anestacon Lidocaine hydrochloride Hi-Tech Pharmacal Co., Inc. ANDA Current