FDA.reportPublic FDA data

Application 091248

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL360MGNoNo
002MYCOPHENOLIC ACIDMYCOPHENOLIC ACIDTABLET, DELAYED RELEASE;ORAL180MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-4201Mycophenolic Acidmycophenilic acidMylan Pharmaceuticals Inc.ANDACurrent
0378-4201Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4201Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4201Mycophenolic Acidmycophenilic acidMylan Pharmaceuticals IncANDACurrent
0378-4201Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4201Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4202Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4202Mycophenolic Acidmycophenilic acidMylan Pharmaceuticals IncANDACurrent
0378-4202Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4202Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
0378-4202Mycophenolic Acidmycophenilic acidMylan Pharmaceuticals Inc.ANDACurrent
0378-4202Mycophenolic AcidMycophenolic AcidMylan Pharmaceuticals Inc.ANDACurrent
51079-508Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-508Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-508Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-508Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-509Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-509Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-509Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
51079-509Mycophenolic Acidmycophenilic acidMylan Institutional Inc.ANDACurrent
72819-155Mycophenolic Acidmycophenilic acidArchis Pharma LLCANDACurrent
72819-156Mycophenolic Acidmycophenilic acidArchis Pharma LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
24075ORIG2015-07-06
9326ORIG2014-01-14