FDA.reportPublic FDA data

Application 207873

Type
ANDA
Sponsor
TEVA PHARMS USA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINECAPSULE, DELAYED RELEASE;ORAL400MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-5907MesalamineMesalamineTeva Pharmaceuticals USA, Inc.ANDACurrent
42291-563MesalamineMesalamineAvKARE, IncANDACurrent
42291-563MesalamineMesalamineAvKAREANDACurrent
42291-563MesalamineMesalamineAvKAREANDACurrent
60687-556MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-556MesalamineMesalamineAmerican Health PackagingANDACurrent
60687-556MesalamineMesalamineAmerican Health PackagingANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59081ORIG2019-06-17