FDA.reportPublic FDA data

Application 210465

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LANSOPRAZOLELANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL15MGNoNo
002LANSOPRAZOLELANSOPRAZOLETABLET, ORALLY DISINTEGRATING, DELAYED RELEASE;ORAL30MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-185LansoprazolelansoprazoleNorthStar Rx LLCANDACurrent
16714-185LansoprazolelansoprazoleNorthStar Rx LLCANDACurrent
16714-186LansoprazolelansoprazoleNorthStar Rx LLCANDACurrent
16714-186LansoprazolelansoprazoleNorthStar Rx LLCANDACurrent
43598-560LansoprazolelansoprazoleDr.Reddys Laboratories IncANDACurrent
43598-560LansoprazolelansoprazoleDr.Reddys Laboratories IncANDACurrent
43598-561LansoprazolelansoprazoleDr.Reddys Laboratories IncANDACurrent
43598-561LansoprazolelansoprazoleDr.Reddys Laboratories IncANDACurrent