FDA.reportPublic FDA data

Application 091640

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINETABLET, DELAYED RELEASE;ORAL1.2GMNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6832mesalaminemesalamineMajor PharmaceuticalsANDACurrent
0904-6832mesalaminemesalamineMajor PharmaceuticalsANDACurrent
0904-6832mesalaminemesalamineMajor PharmaceuticalsANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
16714-830mesalaminemesalamineNorthstar Rx LLC.ANDACurrent
50090-4168mesalaminemesalamineA-S Medication SolutionsANDACurrent
60687-397MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-397MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-397MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-397MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-397MesalamineMesalamineAmerican Health PackagingANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-711mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1071mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1071mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1071mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1071mesalaminemesalamineZydus Lifesciences LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
70719ORIG2022-04-07
48668ORIG2017-06-07
48667ORIG2017-06-07