Mitomycin Ophthalmic Solution

Brand(s)
Mitosol
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Mobius Therapeutics Llc (2012-02-29)
Oldest Current Product
2012-02-08
License(s)
NDA
RxNORM
OPHTHALMIC SOLUTION\MITOMYCIN
FDAOB
TOPICAL\FOR SOLUTION\MITOMYCIN

product(s) by strength(s)

mitomycin 0.2 mg/ml ophthalmic solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1497710002MitosolNDAMobius Therapeutics Llc2012-02-08MITOMYCINKITNDA022572244002c6-c61d-43fe-9326-072797113979

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022572MITOSOLMOBIUS THERAPEUTICS LLC2012-02-07p7806265, SUBSTANCE
p8186511, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2019-02-07]NDA022572_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022572_001RXMITOMYCIN (0.2MG/VIAL)TOPICALFOR SOLUTIONTrue2012-02-07MITOSOL

patent(s)

#idexpiration dateapplication(s)
1p7806265 (view patent)2029-02-01NDA022572
2p8186511 (view patent)2026-07-19NDA022572

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1244002c6-c61d-43fe-9326-072797113979 (view SPL)These highlights do not include all the information needed to use Mitosol (mitomycin for solution) safely and effectively. See full prescribing information for Mitosol (mitomycin for solution).Mitosol (mitomycin for solution)Initial U.S. Approval: 1974prescriptionHuman PrescriptionMobius Therapeutics LlcMANUFACTURE2012-02-293497710002

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