Home Applications 019941 Application 019941
Type NDA
Sponsor TEVA BRANDED PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 EMLA LIDOCAINE; PRILOCAINE CREAM;TOPICAL 2.5%;2.5% Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 N019941-001 EMLA LIDOCAINE; PRILOCAINE 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL RLD 1992-12-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N019941-001 EMLA 2.5%;2.5% CREAM / TOPICAL AB RLD, RS 1992-12-30 cb3db0bc1861…
Observed Orange Book normalized TE history# NDC Listings For This Application# NDC listings for this application page 1 of 1 · 35 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 0591-2070 Lidocaine and Prilocaine lidocaine and prilocaine Actavis Pharma, Inc. NDA AUTHORIZED GENERIC Current 51021-375 Priloxx LP External Kit lidocaine and prilocaine cream Sircle Laboratories LLC NDA Current 59088-705 Prizotral lidocaine and prilocaine, lidocaine hydrochloride PureTek Corporation NDA AUTHORIZED Current 59088-705 Prizotral lidocaine and prilocaine, lidocaine hydrochloride PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-706 Nuvakaan lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-706 Nuvakaan lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED Current 59088-711 Aprizio Pak lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED Current 59088-711 Aprizio Pak lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-741 Prilo Patch lidocaine and prilocaine, lidocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-764 Prilo Patch-II lidocaine and prilocaine, lidocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-764 Prilo Patch-II lidocaine and prilocaine, lidocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-764 Prilo Patch-II lidocaine and prilocaine, lidocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-810 DermacinRx Empricaine lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED Current 59088-810 DermacinRx Empricaine lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-873 DermacinRx Prizopak lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED GENERIC Current 59088-873 DermacinRx Prizopak lidocaine and prilocaine PureTek Corporation NDA AUTHORIZED Current 61919-443 LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINE DIRECT RX NDA Current 61919-443 LIDOCAINE AND PRILOCAINE LIDOCAINE AND PRILOCAINE DIRECT RX NDA Current 63187-577 Lidocaine and Prilocaine lidocaine and prilocaine Proficient Rx LP NDA AUTHORIZED GENERIC Current 63187-577 Lidocaine and Prilocaine lidocaine and prilocaine Proficient Rx LP NDA AUTHORIZED GENERIC Current 68071-4639 Lidocaine and Prilocaine lidocaine and prilocaine NuCare Pharmaceuticals,Inc. NDA AUTHORIZED GENERIC Current 68788-8955 Lidocaine and Prilocaine lidocaine and prilocaine Preferred Pharmaceuticals Inc. NDA AUTHORIZED GENERIC Current 69176-140 Lido-Prilo Caine Pack lidocaine and prilocaine TMIG Inc. NDA AUTHORIZED GENERIC Current 69336-825 LIDOPRIL Lidocaine 2.5% and Prilocaine 2.5% Sterling-knight Pharmaceuticals,LLC NDA Current 69336-826 LIDOPRIL XR Lidocaine 2.5% and Prilocaine 2.5% Sterling-knight Pharmaceuticals,LLC NDA Current 69336-828 PRILOLID Lidocaine 2.5% and Prilocaine 2.5% Sterling-knight Pharmaceuticals,LLC NDA Current 69621-810 Prikaan Lite lidocaine and prilocaine Shoreline Pharmaceuticals NDA AUTHORIZED Current 69621-828 Prikaan lidocaine and prilocaine Shoreline Pharmaceuticals NDA AUTHORIZED Current 69621-873 DermacinRx Prikaan lidocaine and prilocaine Shoreline Pharmaceuticals, Inc. NDA AUTHORIZED GENERIC Current 71248-001 Anodyne LPT lidocaine and prilocaine Fortus Pharma, LLC NDA AUTHORIZED GENERIC Current