FDA.reportPublic FDA data

Application 021598

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIGAMOXMOXIFLOXACIN HYDROCHLORIDESOLUTION/DROPS;OPHTHALMICEQ 0.5% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-4013VIGAMOXmoxifloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4013VIGAMOXmoxifloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4013VIGAMOXmoxifloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4013VIGAMOXmoxifloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0065-4013VIGAMOXmoxifloxacin hydrochlorideAlcon Laboratories, Inc.NDACurrent
0078-0939VIGAMOXmoxifloxacin hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0078-0939VIGAMOXmoxifloxacin hydrochlorideNovartis Pharmaceuticals CorporationNDACurrent
0781-7135Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-7135Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
0781-7135Moxifloxacin Ophthalmic Solutionmoxifloxacin hydrochlorideSandoz IncNDA AUTHORIZED GENERICCurrent
21695-968VIGAMOXmoxifloxacin hydrochlorideRebel Distributors CorpNDACurrent
50090-0859VIGAMOXmoxifloxacin hydrochlorideA-S Medication SolutionsNDACurrent
50090-0859VIGAMOXmoxifloxacin hydrochlorideA-S Medication SolutionsNDACurrent
70518-2043VIGAMOXmoxifloxacin hydrochlorideREMEDYREPACK INC.NDACurrent
70518-2043VIGAMOXmoxifloxacin hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63423SUPPL2020-06-05
63407SUPPL2020-06-03
62944SUPPL2020-05-13
62909SUPPL2020-05-12
47627SUPPL2017-03-21
47585SUPPL2017-03-20
37315SUPPL2011-10-12
5820SUPPL2011-10-12
42228ORIG2005-04-08
37314SUPPL2004-07-01
28225SUPPL2004-07-01
15854SUPPL2004-05-03
28224SUPPL2004-04-20
37313SUPPL2003-10-10
15853SUPPL2003-10-10
28223SUPPL2003-10-03
5819SUPPL2003-10-03
28222ORIG2003-05-29
15852ORIG2003-04-17
51389ORIG1900-01-01
51388ORIG1900-01-01