Mechlorethamine Topical Gel

Brand(s)
Valchlor
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Ceptaris Therapeutics, Inc. (2013-08-31)
Oldest Current Product
2013-10-21
License(s)
NDA
RxNORM
TOPICAL GEL\MECHLORETHAMINE
FDAOB
TOPICAL\GEL\MECHLORETHAMINE HYDROCHLORIDE
SPL Active
TOPICAL\GEL\MECHLORETHAMINE
SPL Moiety
TOPICAL\GEL\MECHLORETHAMINE

product(s) by strength(s)

mechlorethamine 0.00016 mg/mg topical gel

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1424270002ValchlorNDACeptaris Therapeutics, Inc.2013-10-21MECHLORETHAMINETOPICALGELNDA202317706bd420-2f32-11e0-aaee-0002a5d5c51b

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202317VALCHLORACTELION PHARMACEUTICALS LTD2013-08-23p7872050, ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN DIRECTED THERAPY
p7838564, SUBSTANCE
p8501819, ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN DIRECTED THERAPY
p8450375, SUBSTANCE
p8501818, SUBSTANCE
NEW DOSAGE FORM [2016-08-23]
ORPHAN DRUG EXCLUSIVITY [2020-08-23]
NDA202317_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202317_001RXMECHLORETHAMINE HYDROCHLORIDE (EQ 0.016% BASE)TOPICALGELTrue2013-08-23VALCHLOR

patent(s)

#idexpiration dateapplication(s)
1p7838564 (view patent)2026-03-07NDA202317
2p7872050 (view patent)2029-07-08NDA202317
3p8450375 (view patent)2026-03-07NDA202317
4p8501818 (view patent)2026-03-07NDA202317
5p8501819 (view patent)2026-03-07NDA202317

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1706bd420-2f32-11e0-aaee-0002a5d5c51b (view SPL)These highlights do not include all the information needed to use VALCHLOR safely and effectively. See full prescribing information for VALCHLOR. VALCHLOR (mechlorethamine) gel, for topical use Initial U.S. Approval: 1949prescriptionHuman PrescriptionCeptaris Therapeutics, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2013-08-313424270002
2f522cd6d-aa0f-4b44-92cc-ed952058eea0 (view SPL)These highlights do not include all the information needed to use VALCHLOR safely and effectively. See full prescribing information for VALCHLOR. VALCHLOR (mechlorethamine) gel, for topical use Initial U.S. Approval: 1949prescriptionHuman PrescriptionActelion Pharmaceuticals Us, Inc.ANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-105662150016

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