FDA.reportPublic FDA data

Application 076751

Type
ANDA
Sponsor
PERRIGO ISRAEL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MESALAMINEMESALAMINEENEMA;RECTAL4GM/60MLNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45802-098MesalamineMesalaminePerrigo New York IncANDACurrent
45802-098MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-098MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-098MesalamineMesalaminePerrigo New York IncANDACurrent
45802-098MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-098MesalamineMesalaminePerrigo New York IncANDACurrent
45802-098MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-923MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-923MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-923MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-923MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-923MesalamineMesalaminePerrigo New York IncANDACurrent
45802-929MesalamineMesalaminePerrigo New York IncANDACurrent
45802-929MesalamineMesalaminePerrigo New York IncANDACurrent
45802-929MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-929MesalamineMesalaminePerrigo New York IncANDACurrent
45802-929MesalamineMesalaminePerrigo New York IncANDACurrent
45802-929MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
45802-929MesalamineMesalaminePadagis Israel Pharmaceuticals LtdANDACurrent
63629-8678MesalamineMesalamineBryant Ranch PrepackANDACurrent
63629-8678MesalamineMesalamineBryant Ranch PrepackANDACurrent
63629-8678MesalamineMesalamineBryant Ranch PrepackANDACurrent
63629-8679MesalamineMesalamineBryant Ranch PrepackANDACurrent
63629-8679MesalamineMesalamineBryant Ranch PrepackANDACurrent
63629-8679MesalamineMesalamineBryant Ranch PrepackANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22584ORIG2007-04-02
31158ORIG2004-09-17