FDA.reportPublic FDA data

Application 079051

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL20MGNoNo
002NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL30MGNoYes
003NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL40MGNoYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2222NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2222NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2222NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2223NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2223NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2223NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2224NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2224NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2224NisoldipineNisoldipineMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
31406ORIG2008-07-31