FDA.reportPublic FDA data

Application 208953

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-245MesalamineMesalamineNorthstar Rx LLC.ANDACurrent
16714-245MesalamineMesalamineNorthstar Rx LLC.ANDACurrent
70710-1302MesalamineMesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1302MesalamineMesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1302MesalamineMesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1302MesalamineMesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1513MesalamineMesalamineZydus Lifesciences LimitedANDACurrent
70771-1513MesalamineMesalamineCadila Healthcare LimitedANDACurrent
70771-1513MesalamineMesalamineCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56866ORIG2018-12-20