FDA NDA · NDA016785
MATULANE
Sponsor: LEADIANT BIOSCI INC
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APPLICATION
NDA016785
TYPE
NDA
ORIGINAL APPROVAL
1969-07-22
LATEST ACTION
2026-09-30
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
MATULANE · ReferencePrescription
PROCARBAZINE HYDROCHLORIDE EQ 50MG BASE · CAPSULE · ORAL
Approval history
2016-02-02Manufacturing (CMC) · Supplement 39 · priorityAP
2002-12-20Labeling · Supplement 35 · standardAP
2002-03-13Manufacturing (CMC) · Supplement 34 · priorityAP
2001-11-13Manufacturing (CMC) · Supplement 33 · priorityAP
2001-03-02Manufacturing (CMC) · Supplement 32 · priorityAP
1999-03-08Manufacturing (CMC) · Supplement 31 · priorityAP
1998-10-16Manufacturing (CMC) · Supplement 30 · priorityAP
1987-08-17Labeling · Supplement 26AP
1987-04-09Labeling · Supplement 29AP
1987-03-05Manufacturing (CMC) · Supplement 27 · priorityAP
1986-05-07Labeling · Supplement 28AP
1986-04-29Labeling · Supplement 24AP
1981-12-18Manufacturing (CMC) · Supplement 23 · priorityAP
1981-08-11Labeling · Supplement 19AP
1981-03-31Manufacturing (CMC) · Supplement 22 · priorityAP
1980-07-24Manufacturing (CMC) · Supplement 21 · priorityAP
1980-03-24Labeling · Supplement 18AP
1979-11-14Manufacturing (CMC) · Supplement 20 · priorityAP
1979-01-09Manufacturing (CMC) · Supplement 17 · priorityAP
1978-11-27Manufacturing (CMC) · Supplement 16 · priorityAP
1977-05-16Manufacturing (CMC) · Supplement 14 · priorityAP
1976-04-08Manufacturing (CMC) · Supplement 13 · priorityAP
1969-07-22Type 1 - New Molecular Entity · Original · priorityAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →