FDA.reportPublic FDA data

Application 019941

Type
NDA
Sponsor
TEVA BRANDED PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMLALIDOCAINE; PRILOCAINECREAM;TOPICAL2.5%;2.5%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
0591-2070Lidocaine and Prilocainelidocaine and prilocaineActavis Pharma, Inc.NDA AUTHORIZED GENERICCurrent
51021-375Priloxx LP External Kitlidocaine and prilocaine creamSircle Laboratories LLCNDACurrent
59088-705Prizotrallidocaine and prilocaine, lidocaine hydrochloridePureTek CorporationNDA AUTHORIZED Current
59088-705Prizotrallidocaine and prilocaine, lidocaine hydrochloridePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-706Nuvakaanlidocaine and prilocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-706Nuvakaanlidocaine and prilocainePureTek CorporationNDA AUTHORIZED Current
59088-711Aprizio Paklidocaine and prilocainePureTek CorporationNDA AUTHORIZED Current
59088-711Aprizio Paklidocaine and prilocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-741Prilo Patchlidocaine and prilocaine, lidocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-764Prilo Patch-IIlidocaine and prilocaine, lidocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-764Prilo Patch-IIlidocaine and prilocaine, lidocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-764Prilo Patch-IIlidocaine and prilocaine, lidocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-810DermacinRx Empricainelidocaine and prilocainePureTek CorporationNDA AUTHORIZED Current
59088-810DermacinRx Empricainelidocaine and prilocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-873DermacinRx Prizopaklidocaine and prilocainePureTek CorporationNDA AUTHORIZED GENERICCurrent
59088-873DermacinRx Prizopaklidocaine and prilocainePureTek CorporationNDA AUTHORIZED Current
61919-443LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEDIRECT RXNDACurrent
61919-443LIDOCAINE AND PRILOCAINELIDOCAINE AND PRILOCAINEDIRECT RXNDACurrent
63187-577Lidocaine and Prilocainelidocaine and prilocaineProficient Rx LPNDA AUTHORIZED GENERICCurrent
63187-577Lidocaine and Prilocainelidocaine and prilocaineProficient Rx LPNDA AUTHORIZED GENERICCurrent
68071-4639Lidocaine and Prilocainelidocaine and prilocaineNuCare Pharmaceuticals,Inc.NDA AUTHORIZED GENERICCurrent
68788-8955Lidocaine and Prilocainelidocaine and prilocainePreferred Pharmaceuticals Inc.NDA AUTHORIZED GENERICCurrent
69176-140Lido-Prilo Caine Packlidocaine and prilocaineTMIG Inc.NDA AUTHORIZED GENERICCurrent
69336-825LIDOPRILLidocaine 2.5% and Prilocaine 2.5%Sterling-knight Pharmaceuticals,LLCNDACurrent
69336-826LIDOPRIL XRLidocaine 2.5% and Prilocaine 2.5%Sterling-knight Pharmaceuticals,LLCNDACurrent
69336-828PRILOLIDLidocaine 2.5% and Prilocaine 2.5%Sterling-knight Pharmaceuticals,LLCNDACurrent
69621-810Prikaan Litelidocaine and prilocaineShoreline PharmaceuticalsNDA AUTHORIZED Current
69621-828Prikaanlidocaine and prilocaineShoreline PharmaceuticalsNDA AUTHORIZED Current
69621-873DermacinRx Prikaanlidocaine and prilocaineShoreline Pharmaceuticals, Inc.NDA AUTHORIZED GENERICCurrent
71248-001Anodyne LPTlidocaine and prilocaineFortus Pharma, LLCNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56328SUPPL2018-11-07
56262SUPPL2018-11-05
41102SUPPL2007-12-06
41101SUPPL2007-12-06
20427SUPPL2007-12-06
12081SUPPL2006-05-01
1826SUPPL2006-05-01
1825SUPPL2006-01-19
34110SUPPL2006-01-05
19858SUPPL2004-06-03
41100SUPPL2004-03-24
34109SUPPL2000-01-28
19857SUPPL2000-01-28
19856SUPPL1999-03-11
41099SUPPL1998-02-04
20429SUPPL1998-02-04
20428SUPPL1998-02-04