FDA.reportPublic FDA data

Application 040445

Type
ANDA
Sponsor
SANDOZ

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0185-0448MetaxaloneMetaxaloneEon Labs, Inc.ANDACurrent
0185-0448MetaxaloneMetaxaloneEon Labs, Inc.ANDACurrent
0185-0448MetaxaloneMetaxaloneEon Labs, Inc.ANDACurrent
0185-0448MetaxaloneMetaxaloneEon Labs, Inc.ANDACurrent
21695-585MetaxaloneMetaxaloneRebel Distributors Corp.ANDACurrent
50436-0448MetaxaloneMetaxaloneUnit Dose ServicesANDACurrent
51655-167MetaxaloneMetaxaloneNorthwind PharmaceuticalsANDACurrent
60760-155MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
61919-091METAXALONEMETAXALONEDIRECT RXANDACurrent
61919-091METAXALONEMETAXALONEDIRECT RXANDACurrent
67296-1275MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
67296-1275MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
67296-1275MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
68788-6466MetaxaloneMetaxalonePreferred Pharmaceuticals Inc.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22144SUPPL2013-05-14
22143ORIG2013-01-28
7663ORIG2010-04-05