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FDA NDA · NDA202317

VALCHLOR

mechlorethamine hydrochloride

Sponsor: HELSINN

APPLICATION
NDA202317
TYPE
NDA
ORIGINAL APPROVAL
2013-08-23
LATEST ACTION
2020-05-01
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Prescription

Products

VALCHLOR · ReferencePrescription
MECHLORETHAMINE HYDROCHLORIDE EQ 0.016% BASE · GEL · TOPICAL

Approval history

2020-05-01Labeling · Supplement 10 · standard — Label ↗AP
2020-01-13Labeling · Supplement 9 · standard — Letter ↗AP
2016-12-22Manufacturing (CMC) · Supplement 6 · standardAP
2016-04-08Manufacturing (CMC) · Supplement 5 · standardAP
2015-10-29Labeling · Supplement 4 · standard — Label ↗AP
2014-10-13Manufacturing (CMC) · Supplement 3 · standardAP
2014-07-09Labeling · Supplement 1 · standardAP
2014-07-08Manufacturing (CMC) · Supplement 2 · standardAP
2013-08-23Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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