FDA.reportPublic FDA data

Application 022503

Type
NDA
Sponsor
PRIMUS PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METAXALONEMETAXALONETABLET;ORAL640MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82196SUPPL 2025-05-15
82256SUPPL 2025-05-08
77229SUPPL 2024-01-17
77207SUPPL 2024-01-11
70320SUPPL2022-03-01
70286SUPPL2022-02-28
42541ORIG2015-12-09
24326ORIG2015-12-09
29788ORIG2015-06-09
17650ORIG2015-06-04