FDA.reportPublic FDA data

Application 021717

Type
NDA
Sponsor
TARO PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PLIAGLISLIDOCAINE; TETRACAINECREAM;TOPICAL7%;7%YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0299-6100PLIAGLISlidocaine and tetracaineGalderma Laboratories, L.P.NDACurrent
51672-5305PLIAGLISLidocaine and TetracaineTaro Pharmaceuticals U.S.A., Inc.NDACurrent
51672-5305PLIAGLISLidocaine and TetracaineTaro Pharmaceuticals U.S.A., Inc.NDACurrent
51672-5305PLIAGLISLidocaine and TetracaineTaro Pharmaceuticals U.S.NDACurrent
69420-3077LIDOCAINE AND TETRACAINELIDOCAINE AND TETRACAINESA3, LLCNDA AUTHORIZED GENERICCurrent
69420-3077Lidocaine and Tetracainelidocaine and tetracaineSAE, LLCNDA AUTHORIZED GENERICCurrent
71800-631Lidocaine and TetracaineLidocaine and TetracaineInnovida Pharmaceutique CorporationNDA AUTHORIZED GENERICCurrent
71800-631Lidocaine and TetracaineLidocaine and TetracaineInnovida Pharmaceutique CorporationNDA AUTHORIZED GENERICCurrent
71800-631Lidocaine and TetracaineLidocaine and TetracaineInnovida Pharmaceutique CorporationNDA AUTHORIZED GENERICCurrent
71800-631Lidocaine and TetracaineLidocaine and TetracaineInnovida Pharmaceutique CorporationNDA AUTHORIZED GENERICCurrent
73575-009Pliaglislidocaine and tetracaineOba Pharmaceuticals, Inc.NDACurrent
73575-009Pliaglislidocaine and tetracaineOba Pharmaceuticals, Inc.NDACurrent
73575-010Pliaglislidocaine and tetracaineOba Pharmaceuticals, Inc.NDACurrent
73575-010Pliaglislidocaine and tetracaineOba Pharmaceuticals, Inc.NDACurrent
73575-010Pliaglislidocaine and tetracaineOba Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56861SUPPL2018-12-20
56708SUPPL2018-12-12
56364SUPPL2018-11-08
56272SUPPL2018-11-05
50497SUPPL2017-11-27
50481SUPPL2017-11-24
37512SUPPL2013-11-15
6040SUPPL2013-11-12
42283ORIG2008-10-15
37511SUPPL2007-07-05
28451SUPPL2007-07-05
16250ORIG2006-07-03
6039ORIG2006-07-03