FDA.reportPublic FDA data

Application 203286

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINETABLET, DELAYED RELEASE;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0904-6832mesalaminemesalamineMajor PharmaceuticalsANDACurrent
60687-408MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-408MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-408MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-408MesalamineMesalamineAmerican Health PackagingANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
68382-435mesalaminemesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70710-1543ZALDYONmesalamineZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1110mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1110mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1110mesalaminemesalamineZydus Lifesciences LimitedANDACurrent
70771-1110mesalaminemesalamineCadila Healthcare LimitedANDACurrent
70771-1353ZALDYONmesalamineCadila Healthcare LimitedANDACurrent
70771-1353ZALDYONmesalamineZydus Lifesciences LimitedANDACurrent
70771-1353ZALDYONmesalamineCadila Healthcare LimitedANDACurrent
70771-1353ZALDYONmesalamineCadila Healthcare LimitedANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
65827ORIG2021-01-06
49102ORIG2017-07-27