FDA.reportPublic FDA data

Application 074903

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ETODOLACETODOLACTABLET;ORAL400MGNoNo
002ETODOLACETODOLACTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0675EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0675EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0675EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0675EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0687EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0687EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0687EtodolacEtodolacEon Labs, Inc.ANDACurrent
0185-0687EtodolacEtodolacEon Labs, Inc.ANDACurrent
43063-834EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-834EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-834EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-834EtodolacEtodolacPD-Rx Pharmaceuticals, Inc.ANDACurrent
63629-7128EtodolacEtodolacBryant Ranch PrepackANDACurrent
63629-7128EtodolacEtodolacBryant Ranch PrepackANDACurrent
68788-7068EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7068EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-7068EtodolacEtodolacPreferred Pharmaceuticals Inc.ANDACurrent
68788-9990EtodolacEtodolacPreferred Pharmaceuticals, Inc.ANDACurrent
70934-346EtodolacEtodolacDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-346EtodolacEtodolacDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0602EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0602EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0602EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0640EtodolacEtodolacBryant Ranch PrepackANDACurrent
71335-0640EtodolacEtodolacBryant Ranch PrepackANDACurrent