FDA.reportPublic FDA data

Application 076453

Type
ANDA
Sponsor
FOUGERA PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LIDOCAINE AND PRILOCAINELIDOCAINE; PRILOCAINECREAM;TOPICAL2.5%;2.5%NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0168-0357Lidocaine and Prilocainelidocaine and prilocaineE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0357Lidocaine and Prilocainelidocaine and prilocaineE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0357Lidocaine and Prilocainelidocaine and prilocaineE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
0168-0357Lidocaine and Prilocainelidocaine and prilocaineE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.ANDACurrent
21695-388Lidocaine and PrilocaineLidocaine and PrilocaineRebel Distributors CorpANDACurrent
59088-351DermacinRx Cinlone-I CPIlidocaine and prilocaine, triamcinolone acetonidePureTek CorporationANDACurrent
59088-352DermacinRx Cinlone-II CPIlidocaine and prilocaine, triamcinolone acetonidePureTek CorporationANDACurrent
59088-378Venipuncture CPIlidocaine and prilocainePureTek CorporationANDACurrent
68788-6434Lidocaine and Prilocainelidocaine and prilocainePreferred Pharmaceuticals Inc.ANDACurrent
69837-100PainGo KFTPRILOCAINE, LIDOCAINE, METHYL SALICYLATE, MENTHOLInternational Brand Management, LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43078SUPPL2005-07-22
43077SUPPL2005-07-22
43076ORIG2005-07-22
22561SUPPL2005-07-22
22560SUPPL2005-07-22
22559SUPPL2005-07-22