FDA.reportPublic FDA data

Application 210069

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TADALAFILTADALAFILTABLET;ORAL2.5MGNoNo
002TADALAFILTADALAFILTABLET;ORAL5MGNoNo
003TADALAFILTADALAFILTABLET;ORAL10MGNoNo
004TADALAFILTADALAFILTABLET;ORAL20MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-573TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-573TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-573TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-573TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-574TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-574TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-574TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-574TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-575TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-575TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-575TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-575TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-576TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-576TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-576TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
43598-576TadalafilTadalafilDr.Reddys Laboratories IncANDACurrent
50268-738TadalafilTadalafilAvPAKANDACurrent
50268-738TadalafilTadalafilAvPAKANDACurrent
50268-738TadalafilTadalafilAvPAKANDACurrent
50268-739TadalafilTadalafilAvPAKANDACurrent
50268-739TadalafilTadalafilAvPAKANDACurrent
50268-739TadalafilTadalafilAvPAKANDACurrent