Home Applications 076290 Application 076290
Type ANDA
Sponsor HI TECH PHARMA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% 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 A076290-001 LIDOCAINE AND PRILOCAINE LIDOCAINE; PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25
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 · 42 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 2026-08-18 06:07:40 2026-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL 2003-09-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB 2003-09-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076290-001 LIDOCAINE AND PRILOCAINE 2.5%;2.5% CREAM / TOPICAL AB RS 2003-09-25 e64feba35796…
Observed Orange Book normalized TE history# 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.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 33261-591 Lidocaine and Prilocaine Lidocaine and Prilocaine Aidarex Pharmaceuticals LLC ANDA Current 42254-195 Lidocaine and Prilocaine Lidocaine and Prilocaine Rebel Distributors Corp ANDA Current 50383-667 Lidocaine and Prilocaine Lidocaine and Prilocaine Hi-Tech Pharmacal Co., Inc. ANDA Current 50383-667 Lidocaine and Prilocaine Lidocaine and Prilocaine Akorn ANDA Current 50383-667 Lidocaine and Prilocaine Lidocaine and Prilocaine Akorn ANDA Current 50383-667 Lidocaine and Prilocaine Lidocaine and Prilocaine Hi-Tech Pharmacal Co., Inc. ANDA Current 68071-1625 Lidocaine and Prilocaine Lidocaine and Prilocaine NuCare Pharamceuticals,Inc. ANDA Current 68071-1625 Lidocaine and Prilocaine Lidocaine and Prilocaine NuCare Pharamceuticals,Inc. ANDA Current 68071-1625 Lidocaine and Prilocaine Lidocaine and Prilocaine NuCare Pharamceuticals,Inc. ANDA Current 68788-9774 Lidocaine and Prilocaine Lidocaine and Prilocaine Preferred Pharmaceuticals, Inc. ANDA Current 69166-105 Relador Pak with Occlusive Dressing lidocaine and prilocaine Accelis Pharma ANDA Current 69166-155 Relador Pak lidocaine and prilocaine Accelis Pharma ANDA Current