FDA.reportPublic FDA data

Application 200484

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NIACINNIACINTABLET, EXTENDED RELEASE;ORAL500MGNoNo
002NIACINNIACINTABLET, EXTENDED RELEASE;ORAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
47335-539NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-539NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-539NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-539NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-539NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-613NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-613NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-613NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-613NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent
47335-613NIACINNIACINSun Pharmaceutical Industries, Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
52650ORIG2018-02-15