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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 | LidoSite Patch, Vyteris, Inc., Labeling Revision | Synera (Lidocaine and Tetracaine) Topical Patch, Zars, Approval | EMLA Cream (lidocaine and prilocaine), AstraZeneca, Labeling Revision | Lidoderm (lidocaine) patch, Teikoku Pharma, Labeling Revision | Lidocaine Hydrochloride Injection, Abraxis Pharma, Facility Addition | Pliaglis (lidocaine and tetracaine) Cream, Galderma Labs, Labeling Revision | Zingo (lidocaine hydrochloride monohydrate) Powder, Anesiva Inc., Approval | Lidocaine Hydrochloride and Epinephrine Injection, Hospira, Inc., Approval | Zingo (lidocaine hydrochloride) Intradermal System, Anesiva, Inc., Patient Population Altered | Xylocaine (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision | Xylocaine 4% Preservative Free (lidocaine hydrochloride) Injection, APP Pharmaceuticals, Labeling Revision | Lidoderm (lidocaine) Patch, Teikoku Pharma USA, Inc., Labeling Revision | Oraqix (lidocaine and prilocaine) Periodontal Gel, Dentsply Pharmaceutical, Inc., Labeling Revision | Lidocaine Hydrochloride Preservative Free Injection, Strides Arcolab Ltd., Approval | Oraqix (lidocaine and prilocaine) Gel, Dentsply Pharmaceutical, Inc., Labeling Revision | Lidocaine Hydrochloride Injection, Strides Arcolab, Ltd., Approval | Lidocaine Hydrochloride Jelly, Hi-Tech Pharmacal Co., Inc., Approval
  
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