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 44 .
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N019941-001 EMLA LIDOCAINE; PRILOCAINE 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30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 2 of 2 · 44 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 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…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N019941-001 EMLA 2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD 1992-12-30 a50c72e98297…
Observed Orange Book normalized TE history# 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 · 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