Mitotane Oral Tablet

Brand(s)
Lysodren
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
E.R. Squibb & Sons, L.L.C. (2013-11-29)
Oldest Current Product
2009-06-01
License(s)
NDA
RxNORM
ORAL TABLET\MITOTANE
FDAOB
ORAL\TABLET\MITOTANE
SPL Active
ORAL\TABLET\MITOTANE
SPL Moiety
ORAL\TABLET\MITOTANE

product(s) by strength(s)

mitotane 500 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000153080LysodrenNDAE.R. Squibb & Sons, L.L.C.2009-06-01MITOTANEORALTABLETNDA016885e9fba7d4-a0ec-4bfa-9b5b-ec97a9710fd3

application(s)

#idtitleapplicantapproved drug
1NDA016885LYSODRENBRISTOL MYERS SQUIBBNDA016885_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapplication
1NDA016885_001RXMITOTANE (500MG)ORALTABLETTrueLYSODREN

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1e9fba7d4-a0ec-4bfa-9b5b-ec97a9710fd3 (view SPL)LYSODREN (mitotane tablets, USP)prescriptionHuman PrescriptionE.R. Squibb & Sons, L.L.C.2013-11-297000153080

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