FDA Approval Activities for this Drug…

Duocaine (lidocaine HCl-bupivacaine HCl) Injection, 1%/0.375%, Amphastar NDA 21-496 EMLA Anesthetic Disc (Lidocaine 2.5% & Prilocaine 2.5%), Astra, USA, NDA 20-962 2/4/98 7/8/99 EMLA Anesthetic Disc, AstraZeneca LP NDA 19-941/S14, S15 1/27/03 1/29/03 EMLA Cream (Lidocaine 2.5% & Prilocaine 2.5%), Astra, USA, NDA 19-941/S-010 3/11/99 4/8/99 EMLA Cream (Lidocaine 2.5% & Prilocaine 2.5%), Astra, USA, NDA 19-941/S-008 2/4/98 7/27/99 EMLA Cream (Lidocaine & Prilocaine), AstraZeneca NDA 19-941/S011 1/28/00 2/14/00 2/14/00 EMLA (S-11) Indication:Topical anesthetic for superficial minor surgery of genital mucous membranes and as an adjunct for local infiltration anesthesia in genital mucous membranes. Lidocaine and Prilocaine Cream, 2.5%, Altana, ANDA 76-453 8/18/03 Lidoderm Patch (lidocaine patch 5% w/w), Dermal Patch, Hind Health Care, NDA 20-612 3/19/99 3/29/99 3/29/99 6/17/99 Lidoderm Patch Indications: For the treatment of pain in post-herpetic neuralgia. Lidocaine and Prilocaine Cream, Atrix ANDA 76-320 8/27/03 Lidocaine and Prilocaine Cream, Hi-Tech Pharmacal ANDA 76-290 9/25/03 Lidocaine Hydrochloride in 5% Dextrose Injection in Viaflex Plastic, Baxter Healthcare Corp NDA 18-461/S50 1/23/02 2/5/02 9/10/02 9/10/02 Lidocaine Hydrochloride Jelly USP, 2%, Akorn, ANDA 40-333 2/12/03 Lidocaine Hydrochloride USP, 1% and 2% (5 mL Single Dose Ansyr Plastic Syringe) Injection, Abbott ANDA 40-302 9/28/98 9/28/98 BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE Injection 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) DUOCAINE AMPHASTAR 088390 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG BASE/ML;2% LIGNOSPAN STANDARD DEPROCO 088389 EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG BASE/ML;2% LIGNOSPAN FORTE DEPROCO 089635 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;0.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089649 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1% LIDOCAINE HCL AND EPINEPHRINE Abbott 089650 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089645 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 088571 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% LIDOCAINE HCL AND EPINEPHRINE Abbott 089651 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE Abbott 089644 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% LIDOCAINE HCL AND EPINEPHRINE Abbott 089646 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE Abbott 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;0.5% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;1.5% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.005MG/ML;2% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 006488 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% XYLOCAINE W/ EPINEPHRINE ASTRAZENECA 083389 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;1% LIDOCAINE HCL W/ EPINEPHRINE DELL 083390 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL W/ EPINEPHRINE DELL 021381 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% XYLOCAINE W/ EPINEPHRINE DENTSPLY 021381 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% XYLOCAINE W/ EPINEPHRINE DENTSPLY 040057 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE EASTMAN KODAK 040057 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE EASTMAN KODAK 080504 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE GRAHAM CHEM 080504 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% LIDOCAINE HCL AND EPINEPHRINE GRAHAM CHEM 084729 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% LIDOCATON PHARMATON 084048 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.01MG/ML;2% OCTOCAINE SEPTODONT 084048 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Injection 0.02MG/ML;2% OCTOCAINE SEPTODONT 020530 EPINEPHRINE; LIDOCAINE HYDROCHLORIDE Solution; Iontophoresis 2% IONTOCAINE IOMED 020575 LIDOCAINE Film, Extended Release; Buccal 46.1MG/PATCH LIDOCAINE NOVEN 020612 LIDOCAINE Film, Extended Release; Topical 700MG/12HR LIDODERM TEIKOKU USA 084947 AT LIDOCAINE Ointment; Topical 5% ALPHACAINE CARLISLE 080198 AT LIDOCAINE Ointment; Topical 5% LIDOCAINE FOUGERA 080210 AT LIDOCAINE Ointment; Topical 5% LIDOCAINE GRAHAM CHEM 086724 AT LIDOCAINE Ointment; Topical 5% LIDOCAINE Taro 088325 LIDOCAINE HYDROCHLORIDE Injection 0.5% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 088328 LIDOCAINE HYDROCHLORIDE Injection 0.5% LIDOCAINE HCL Abbott 040302 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL PRESERVATIVE FREE IN PLASTIC CONTAINER Abbott 040013 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL Abbott 083158 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL Abbott 088329 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL Abbott 080408 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL PRESERVATIVE FREE Abbott 088299 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 088326 LIDOCAINE HYDROCHLORIDE Injection 1.5% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 080408 LIDOCAINE HYDROCHLORIDE Injection 1.5% LIDOCAINE HCL PRESERVATIVE FREE Abbott 088367 LIDOCAINE HYDROCHLORIDE Injection 10% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 088327 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 088331 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL Abbott 088294 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL Abbott 083158 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL Abbott 040078 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL Abbott 040302 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL PRESERVATIVE FREE IN PLASTIC CONTAINER Abbott 083158 LIDOCAINE HYDROCHLORIDE Injection 20% LIDOCAINE HCL Abbott 088368 LIDOCAINE HYDROCHLORIDE Injection 20% LIDOCAINE HCL IN PLASTIC CONTAINER Abbott 083158 LIDOCAINE HYDROCHLORIDE Injection 200MG/100ML LIDOCAINE HCL 0.2% IN DEXTROSE 5% Abbott 018388 LIDOCAINE HYDROCHLORIDE Injection 200MG/100ML LIDOCAINE HCL 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 088295 LIDOCAINE HYDROCHLORIDE Injection 4% LIDOCAINE HCL PRESERVATIVE FREE Abbott 018388 LIDOCAINE HYDROCHLORIDE Injection 400MG/100ML LIDOCAINE HCL 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 083158 LIDOCAINE HYDROCHLORIDE Injection 400MG/100ML LIDOCAINE HCL 0.4% IN DEXTROSE 5% Abbott 018388 LIDOCAINE HYDROCHLORIDE Injection 800MG/100ML LIDOCAINE HCL 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER Abbott 080404 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL PRESERVATIVE FREE AM PARTNERS 088586 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL IN PLASTIC CONTAINER AM PARTNERS 080404 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL PRESERVATIVE FREE AM PARTNERS 017584 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL PRESERVATIVE FREE AM PARTNERS 017584 LIDOCAINE HYDROCHLORIDE Injection 4% LIDOCAINE HCL PRESERVATIVE FREE AM PARTNERS 006488 LIDOCAINE HYDROCHLORIDE Injection 0.5% XYLOCAINE ASTRAZENECA 006488 LIDOCAINE HYDROCHLORIDE Injection 1% XYLOCAINE ASTRAZENECA 016801 LIDOCAINE HYDROCHLORIDE Injection 1% XYLOCAINE PRESERVATIVE FREE ASTRAZENECA 006488 LIDOCAINE HYDROCHLORIDE Injection 1.5% XYLOCAINE ASTRAZENECA 016801 LIDOCAINE HYDROCHLORIDE Injection 10% XYLOCAINE PRESERVATIVE FREE ASTRAZENECA 016801 LIDOCAINE HYDROCHLORIDE Injection 2% XYLOCAINE PRESERVATIVE FREE ASTRAZENECA 016801 LIDOCAINE HYDROCHLORIDE Injection 20% XYLOCAINE PRESERVATIVE FREE ASTRAZENECA 010417 LIDOCAINE HYDROCHLORIDE Injection 4% XYLOCAINE 4% PRESERVATIVE FREE ASTRAZENECA 016801 LIDOCAINE HYDROCHLORIDE Injection 4% XYLOCAINE PRESERVATIVE FREE ASTRAZENECA 019830 LIDOCAINE HYDROCHLORIDE Injection 200MG/100ML LIDOCAINE HCL 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 018967 LIDOCAINE HYDROCHLORIDE Injection 200MG/100ML LIDOCAINE HCL 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 019830 LIDOCAINE HYDROCHLORIDE Injection 400MG/100ML LIDOCAINE HCL 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 018967 LIDOCAINE HYDROCHLORIDE Injection 400MG/100ML LIDOCAINE HCL 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 019830 LIDOCAINE HYDROCHLORIDE Injection 800MG/100ML LIDOCAINE HCL 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 018967 LIDOCAINE HYDROCHLORIDE Injection 800MG/100ML LIDOCAINE HCL 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER B BRAUN 018461 LIDOCAINE HYDROCHLORIDE Injection 200MG/100ML LIDOCAINE HCL 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER Baxter 018461 LIDOCAINE HYDROCHLORIDE Injection 400MG/100ML LIDOCAINE HCL 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER Baxter 018461 LIDOCAINE HYDROCHLORIDE Injection 800MG/100ML LIDOCAINE HCL 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER Baxter 021380 LIDOCAINE HYDROCHLORIDE Injection 2% XYLOCAINE DENTSPLY 080504 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL GRAHAM CHEM 083173 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL INTL MEDICATION 083173 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL INTL MEDICATION 017702 LIDOCAINE HYDROCHLORIDE Injection 20% LIDOCAINE HCL PRESERVATIVE FREE INTL MEDICATION 080850 LIDOCAINE HYDROCHLORIDE Injection 1% LIDOCAINE HCL LUITPOLD 083198 LIDOCAINE HYDROCHLORIDE Injection 2% LIDOCAINE HCL LUITPOLD 017549 LIDOCAINE HYDROCHLORIDE Injection 10% LIDOPEN MERIDIAN MEDCL TECHN 083914 LIDOCAINE HYDROCHLORIDE Spinal 5% LIDOCAINE HCL 5% AND DEXTROSE 7.5% Abbott 016297 LIDOCAINE HYDROCHLORIDE Spinal 1.5% XYLOCAINE 1.5% W/ DEXTROSE 7.5% ASTRAZENECA 040433 AT LIDOCAINE HYDROCHLORIDE Jelly; Topical 2% LIDOCAINE HCL Akorn 008816 AT LIDOCAINE HYDROCHLORIDE Jelly; Topical 2% XYLOCAINE ASTRAZENECA 081318 AT LIDOCAINE HYDROCHLORIDE Jelly; Topical 2% LIDOCAINE HCL Copley 086283 AT LIDOCAINE HYDROCHLORIDE Jelly; Topical 2% LIDOCAINE HCL INTL MEDICATION 086578 AT LIDOCAINE HYDROCHLORIDE Solution; 2% LIDOCAINE HCL VISCOUS ALPHARMA 009470 AT LIDOCAINE HYDROCHLORIDE Solution; 2% XYLOCAINE VISCOUS ASTRAZENECA 040014 AT LIDOCAINE HYDROCHLORIDE Solution; 2% LIDOCAINE HCL HI TECH 087872 AT LIDOCAINE HYDROCHLORIDE Solution; 2% LIDOCAINE HCL Morton Grove 088802 AT LIDOCAINE HYDROCHLORIDE Solution; 2% LIDOCAINE VISCOUS Roxane 085995 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 2% PEDIATRIC LTA KIT Abbott 080409 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% LTA II KIT Abbott 088542 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% LTA II KIT Abbott 010417 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% XYLOCAINE 4% PRESERVATIVE FREE ASTRAZENECA 086364 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% LARYNG-O-JET KIT INTL MEDICATION 087881 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% LIDOCAINE HCL Morton Grove 080429 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 2% ANESTACON POLYMEDICA 088803 AT LIDOCAINE HYDROCHLORIDE Solution; Topical 4% LIDOCAINE HCL Roxane 060567 LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE Injection 2%;125MG/ML TERRAMYCIN PFIZER 060567 LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE Injection 2%;50MG/ML TERRAMYCIN PFIZER 076453 LIDOCAINE; PRILOCAINE Cream; Topical 2.5%;2.5% LIDOCAINE AND PRILOCAINE Altana 019941 LIDOCAINE; PRILOCAINE Cream; Topical 2.5%;2.5% EMLA ASTRAZENECA 076320 LIDOCAINE; PRILOCAINE Cream; Topical 2.5%;2.5% LIDOCAINE AND PRILOCAINE Atrix 076290 LIDOCAINE; PRILOCAINE Cream; Topical 2.5%;2.5% LIDOCAINE AND PRILOCAINE HI TECH 020962 LIDOCAINE; PRILOCAINE Disc; Topical 2.5%;2.5% EMLA ASTRAZENECA Lidocaine Hydrochloride in 5% Dextrose Injection, B.Braun Medical Xylocaine (lidocaine HCl) 2% Jelly, AstraZeneca, Labeling Revision | Lidocaine HCl 2% and Epinephrine 1:100,000 Solution for Topical Iontophoretic System, Empi, Inc., Approval

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