FDA.reportPublic FDA data

Application 206547

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 100MG BASENoNo
002IMATINIB MESYLATEIMATINIB MESYLATETABLET;ORALEQ 400MG BASENoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-344ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent
43598-345ImatinibImatinibDr.Reddy's Laboratories IncANDACurrent