Application 201452

Type
ANDA
Sponsor
NATCO PHARMA LTD

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0480-1242LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1242LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1243LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1243LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1244LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1244LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1246LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent
0480-1246LenalidomideLenalidomideTeva Pharmaceuticals, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76517ORIG 2023-11-07
67670ORIG2021-06-03