Edetate Calcium Injectable Solution

Brand(s)
Calcium Disodium Versenate
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Medicis, The Dermatology Company (2013-07-02)
Oldest Current Product
2009-07-09
License(s)
NDA
RxNORM
INJECTABLE SOLUTION\EDETATE CALCIUM
FDAOB
INJECTION\INJECTION\EDETATE CALCIUM DISODIUM\rdfq
ORAL\TABLET\EDETATE CALCIUM DISODIUM
SPL Active
INTRAMUSCULAR\INJECTION\EDETATE CALCIUM DISODIUM
SPL Moiety
INTRAMUSCULAR\INJECTION\EDETIC ACID

product(s) by strength(s)

edetate calcium disodium 200 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formapplicationspl
1293360400Calcium Disodium VersenateNDAGraceway Pharmaceuticals, Llc2009-07-092015-12-31EDETATE CALCIUM DISODIUMINTRAMUSCULARINJECTIONNDA008922e71cc7d9-4093-4a5c-aeda-06b54a354499
2992070240Calcium Disodium VersenateNDAMedicis, The Dermatology Company2013-06-21EDETATE CALCIUM DISODIUMINTRAMUSCULARINJECTIONNDA00892274435a8a-28a9-4080-93d0-d9d5f10b325e

application(s)

#idtitleapplicantapproved drug
1NDA008922CALCIUM DISODIUM VERSENATEMEDICIS PHARMACEUTICAL CORPNDA008922_001, NDA008922_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1NDA008922_001RXEDETATE CALCIUM DISODIUM (200MG/ML)INJECTIONTrueCALCIUM DISODIUM VERSENATE
2NDA008922_002discontinuedEDETATE CALCIUM DISODIUM (500MG)ORALTABLETFalseCALCIUM DISODIUM VERSENATE

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
174435a8a-28a9-4080-93d0-d9d5f10b325e (view SPL)Calcium Disodium Versenate (edetate calcium disodium injection, USP)prescriptionHuman PrescriptionMedicis, The Dermatology CompanyMANUFACTURE2013-07-025992070240
2e71cc7d9-4093-4a5c-aeda-06b54a354499 (view SPL)Intravenous or Intramuscular UseprescriptionHuman PrescriptionGraceway Pharmaceuticals, LlcMANUFACTURE2007-09-195293360400
3f960dbfa-b00c-4f3e-ad32-ed6a5deea831 (view SPL)prescriptionHuman Prescription3M Pharmaceuticals2007-09-194000890510

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII