FDA.reportPublic FDA data

Application 209878

Type
ANDA
Sponsor
MSN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL125MGNoNo
002DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL250MGNoNo
003DEFERASIROXDEFERASIROXTABLET, FOR SUSPENSION;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-854DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
43598-854DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
43598-855DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
43598-855DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
43598-856DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
43598-856DeferasiroxDeferasiroxDr. Reddy's Laboratories IncANDACurrent
69539-021DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-021DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-022DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-022DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-023DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent
69539-023DeferasiroxDeferasiroxMSN LABORATORIES PRIVATE LIMITEDANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61211ORIG2019-12-10