FDA.reportPublic FDA data

Application 008922

Type
NDA
Sponsor
MEDICIS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CALCIUM DISODIUM VERSENATEEDETATE CALCIUM DISODIUMINJECTABLE;INJECTION200MG/MLYesYes
002CALCIUM DISODIUM VERSENATEEDETATE CALCIUM DISODIUMTABLET;ORAL500MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
99207-240Calcium Disodium VersenateEDETATE CALCIUM DISODIUMMedicis Pharmaceutical CorpNDACurrent
99207-240Calcium Disodium VersenateEDETATE CALCIUM DISODIUMBausch Health US, LLCNDACurrent
99207-240Calcium Disodium VersenateEDETATE CALCIUM DISODIUMBausch Health US, LLCNDACurrent
99207-240Calcium Disodium VersenateEDETATE CALCIUM DISODIUMBausch Health Us, LLCNDACurrent
99207-240Calcium Disodium VersenateEDETATE CALCIUM DISODIUMBausch Health Us, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
75653SUPPL 2023-10-03
75641SUPPL 2023-10-03
73694SUPPL 2023-03-07
73657SUPPL 2023-03-03
32980SUPPL2009-06-05
172SUPPL2009-05-26