Application 065017

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CYCLOSPORINECYCLOSPORINECAPSULE;ORAL100MGNoNo
002CYCLOSPORINECYCLOSPORINECAPSULE;ORAL25MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0932CyclosporineCyclosporineEon Labs, Inc.ANDACurrent
0185-0932CyclosporineCyclosporineEon Labs, Inc.ANDACurrent
0185-0933CyclosporineCyclosporineEon Labs, Inc.ANDACurrent
0185-0933CyclosporineCyclosporineEon Labs, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
42802ORIG2001-06-07
39414ORIG2000-01-13
8371ORIG2000-01-13