FDA.reportPublic FDA data

Application 013217

Type
NDA
Sponsor
KING PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SKELAXINMETAXALONETABLET;ORAL400MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003SKELAXINMETAXALONETABLET;ORAL800MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0115-1748MetaxaloneMetaxaloneAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1748MetaxaloneMetaxaloneAmneal Pharmaceuticals of New York LLCNDACurrent
0115-1748MetaxaloneMetaxaloneImpax GenericsNDACurrent
10544-002MetaxaloneMetaxaloneBlenheim Pharmacal, Inc.NDACurrent
10544-524SKELAXINmetaxaloneBlenheim Pharmacal, Inc.NDACurrent
21695-123SkelaxinMetaxaloneRebel Distributors CorpNDACurrent
35356-570MetaxaloneMetaxaloneLake Erie Medical & Surgical Supply DBA Quality Care Products LLCNDACurrent
42254-040MetaxaloneMetaxaloneRebel Distributors CorpNDACurrent
43063-239MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-239MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-239MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-239MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
43063-581MetaxaloneMetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
50436-3024MetaxaloneMetaxaloneUnit Dose ServicesNDACurrent
51655-163MetaxaloneMetaxaloneNorthwind PharmaceuticalsNDACurrent
52959-596MetaxaloneMetaxaloneH.J. Harkins Company, Inc.NDACurrent
55289-736SKELAXINmetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-736SKELAXINmetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-736SKELAXINmetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-736SKELAXINmetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
55289-736SKELAXINmetaxalonePD-Rx Pharmaceuticals, Inc.NDACurrent
60793-136SKELAXINmetaxalonePfizer Laboratories Div Pfizer IncNDACurrent
60793-136SKELAXINmetaxalonePfizer Laboratories Div Pfizer IncNDACurrent
61919-346METAXALONEMETAXALONEDIRECT RXNDACurrent
61919-346METAXALONEMETAXALONEDIRECT RXNDACurrent
63629-2768MetaxaloneMetaxaloneBryant Ranch PrepackNDACurrent
64720-321MetaxaloneMetaxaloneCorePharma, LLCNDACurrent
64720-321MetaxaloneMetaxaloneCorePharma, LLCNDACurrent
68151-4668MetaxaloneMetaxaloneCarilion Materials ManagementNDACurrent
68258-7100MetaxaloneMetaxaloneDispensing Solutions, Inc.NDACurrent
68788-0881SkelaxinMetaxalonePreferred Pharmaceuticals, IncNDACurrent
68788-9896MetaxaloneMetaxalonePreferred Pharmaceuticals, Inc.NDACurrent
70518-1161MetaxaloneMetaxaloneREMEDYREPACK INC.NDACurrent
70518-1161MetaxaloneMetaxaloneREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78879SUPPL 2024-06-24
78871SUPPL 2024-06-24
52908SUPPL2018-03-12
52874SUPPL2018-03-08
33103SUPPL2012-11-27
40686SUPPL2009-09-14
40685SUPPL2009-09-14
40684SUPPL2009-09-14
20043SUPPL2009-09-14
20041SUPPL2009-09-14
12045SUPPL2008-11-03
33102SUPPL2006-12-04
12044SUPPL2006-12-04
20042SUPPL2006-05-10
10831SUPPL2002-08-30
355SUPPL2002-08-30
356SUPPL2002-06-20