FDA.reportPublic FDA data

Application 208774

Type
ANDA
Sponsor
APPCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METAXALONEMETAXALONETABLET;ORAL800MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-2398MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
63629-2398MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
64980-472MetaxaloneMetaxaloneRising Pharmaceuticals, Inc.ANDACurrent
67296-1778MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
67296-1778MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
68788-7499MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7499MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7499MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
70518-2275MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-2275MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-2275MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-2275MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70934-429MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-429MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-429MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-470MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-961MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-961MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71335-1320MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
72789-122MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-122MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-122MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.ANDACurrent
80175-0472MetaxaloneMetaxaloneCentral PackagingANDACurrent
80175-0472MetaxaloneMetaxaloneCentral PackagingANDACurrent
80175-0472MetaxaloneMetaxaloneCentral PackagingANDACurrent