Application 209348

Type
ANDA
Sponsor
DR REDDYS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LENALIDOMIDELENALIDOMIDECAPSULE;ORAL2.5MGNoNo
002LENALIDOMIDELENALIDOMIDECAPSULE;ORAL20MGNoNo
003LENALIDOMIDELENALIDOMIDECAPSULE; ORAL5MGNoNo
004LENALIDOMIDELENALIDOMIDECAPSULE; ORAL10MGNoNo
005LENALIDOMIDELENALIDOMIDECAPSULE; ORAL15MGNoNo
006LENALIDOMIDELENALIDOMIDECAPSULE; ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43598-511LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-511LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-511LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-511LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-512LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-512LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-512LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-512LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-513LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-513LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-513LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-513LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-514LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-514LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-514LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-514LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-515LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-515LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-515LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-515LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-516LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-516LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-516LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent
43598-516LenalidomideLenalidomideDr. Reddy's Laboratories Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76520ORIG 2023-11-07
69188ORIG2021-11-02
69187ORIG2021-11-02