Application 075861

Type
ANDA
Sponsor
AM REGENT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCARNITINELEVOCARNITINEINJECTABLE;INJECTION200MG/MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0517-1045LevocarnitineLevocarnitineAmerican Regent, Inc.ANDACurrent
0517-1045LevocarnitineLevocarnitineAmerican Regent, Inc.ANDACurrent
0517-1045LevocarnitineLevocarnitineAmerican Regent, Inc.ANDACurrent
0517-1045LevocarnitineLevocarnitineAmerican Regent, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31037ORIG2001-06-22