FDA.reportPublic FDA data

Application 020191

Type
NDA
Sponsor
NOVARTIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ALOMIDELODOXAMIDE TROMETHAMINESOLUTION/DROPS;OPHTHALMICEQ 0.1% BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0065-0345ALOMIDElodoxamide tromethamineAlcon Laboratories, Inc.NDACurrent
0065-0345ALOMIDElodoxamide tromethamineAlcon Laboratories, Inc.NDACurrent
0065-0345ALOMIDElodoxamide tromethamineAlcon Laboratories, Inc.NDACurrent
0065-0345ALOMIDElodoxamide tromethamineAlcon Laboratories, Inc.NDACurrent
0065-0345ALOMIDElodoxamide tromethamineAlcon Laboratories, Inc.NDACurrent
0078-0736ALOMIDElodoxamide tromethamineNovartis Pharmaceuticals CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
34357SUPPL2003-07-08
24557SUPPL2003-07-06