FDA.reportPublic FDA data

Application 204770

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

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

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
0527-1435MetaxaloneMetaxaloneLannett Company, Inc.ANDACurrent
45865-942MetaxaloneMetaxalonemedsource pharmaceuticalsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3650MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3670MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50090-3670MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-494MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
60760-289MetaxaloneMetaxaloneSt. Mary's Medical Park PharmacyANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
61919-832MetaxaloneMetaxaloneDirect_RxANDACurrent
61919-832MetaxaloneMetaxaloneDirect_RxANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
61919-832METAXALONEMETAXALONEDIRECT RXANDACurrent
63629-2097MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
63629-2097MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
68071-2849MetaxaloneMetaxaloneNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7675MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
69306-311MetaxaloneMetaxaloneDoc RxANDACurrent
70332-330MetaxaloneMetaxaloneCalifornia Pharmaceuticals, LLCANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70518-0771MetaxaloneMetaxaloneREMEDYREPACK INC.ANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-286MetaxaloneMetaxaloneDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71205-426MetaxaloneMetaxaloneProficient Rx LPANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0958MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-1696MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-1696MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-2066MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
76420-232MetaxaloneMetaxaloneAsclemed USA, Inc.ANDACurrent
80425-0122SkelaxinMetaxalone 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0122MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0122MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent