FDA.reportPublic FDA data

Application 204354

Type
ANDA
Sponsor
MYLAN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINESUPPOSITORY;RECTAL1GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-9230MesalaminemesalamineMylan Pharmaceuticals Inc.ANDACurrent
0378-9230MesalaminemesalamineMylan Pharmaceuticals Inc.ANDACurrent
0378-9230MesalaminemesalamineMylan Pharmaceuticals Inc.ANDACurrent
0378-9230MesalaminemesalamineMylan Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
19550ORIG2015-12-01
10331ORIG2015-11-27