Application 203399

Type
ANDA
Sponsor
AMNEAL PHARMS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001METAXALONEMETAXALONETABLET;ORAL800MGNoNo

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-144MetaxaloneMetaxaloneBlenheim Pharmacal, Inc.ANDACurrent
33261-724MetaxaloneMetaxaloneAidarex Pharmaceuticals LLCANDACurrent
42291-587MetaxaloneMetaxaloneAvKARE, Inc.ANDACurrent
42291-587MetaxaloneMetaxaloneAvKAREANDACurrent
42291-587MetaxaloneMetaxaloneAvKARE, Inc.ANDACurrent
50090-1182MetaxaloneMetaxaloneA-S Medication SolutionsANDACurrent
50268-530MetaxaloneMetaxaloneAvPAKANDACurrent
50268-530MetaxaloneMetaxaloneAvPAKANDACurrent
50268-530MetaxaloneMetaxaloneAvPAKANDACurrent
51021-333MetaxallMetaxaloneSircle Laboratories, LLCANDACurrent
51655-162MetaxaloneMetaxaloneNorthwind PharmaceuticalsANDACurrent
53746-553MetaxaloneMetaxaloneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-553MetaxaloneMetaxaloneAmneal Pharmaceuticals of New York LLCANDACurrent
53746-553MetaxaloneMetaxaloneAmneal Pharmaceuticals of New York LLCANDACurrent
55700-342MetaxaloneMetaxaloneLake Erie Medical DBA Quality Care Products LLCANDACurrent
61919-262METAXALONEmetaxalone tabletDirect RXANDACurrent
61919-262METAXALONEmetaxalone tabletDirect RXANDACurrent
63187-490MetaxaloneMetaxaloneProficient Rx LPANDACurrent
63187-490MetaxaloneMetaxaloneProficient Rx LPANDACurrent
63187-490MetaxaloneMetaxaloneProficient Rx LPANDACurrent
65162-553MetaxaloneMetaxaloneAmneal Pharmaceuticals LLCANDACurrent
65162-553MetaxaloneMetaxaloneAmneal Pharmaceuticals LLCANDACurrent
65162-553MetaxaloneMetaxaloneAmneal Pharmaceuticals LLCANDACurrent
65162-553MetaxaloneMetaxaloneAmneal Pharmaceuticals LLCANDACurrent
67296-0993MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
67296-0993MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
67296-0993MetaxaloneMetaxaloneRedPharm Drug, Inc.ANDACurrent
68001-004MetaxaloneMetaxaloneBluePoint LaboratoriesANDACurrent
68001-004MetaxaloneMetaxaloneBluePoint LaboratoriesANDACurrent
68084-135MetaxaloneMetaxaloneAmerican Health PackagingANDACurrent
68084-135MetaxaloneMetaxaloneAmerican Health PackagingANDACurrent
68084-135MetaxaloneMetaxaloneAmerican Health PackagingANDACurrent
68084-135MetaxaloneMetaxaloneAmerican Health PackagingANDACurrent
68788-9277MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.ANDACurrent
70934-160MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-160MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-160MetaxaloneMetaxaloneDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0186MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0186MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
71335-0186MetaxaloneMetaxaloneBryant Ranch PrepackANDACurrent
80425-0084SkelaxinMetaxalone 800mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0084MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0084MetaxaloneMetaxaloneAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent