FDA.reportPublic FDA data

Application 091001

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL8.5MGNoNo
002NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL17MGNoNo
003NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL25.5MGNoNo
004NISOLDIPINENISOLDIPINETABLET, EXTENDED RELEASE;ORAL34MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-2096NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2096NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2096NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2097NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2097NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2097NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2098NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2098NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2098NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2099NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2099NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent
0378-2099NisoldipinenisoldipineMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9309ORIG2011-02-03