Matulane

Treats Stage III or Stage IV Hodgkin Lymphoma. NDA 16785, held by Leadiant Biosci Inc. Procarbazine Hydrochloride.

As of Nov 13, 2026, NDA 16785 (Matulane), held by Leadiant Biosci Inc, was first approved by FDA on Jul 22, 1969, with 23 approved supplements and 0 published complete response letters.

First approved: Jul 22, 1969
Review: Priority
Supplements approved: 23
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

MATULANE is indicated for use in combination with other anticancer drugs for the treatment of Stage III or Stage IV Hodgkin Lymphoma.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 24 submissions below

Date	Submission	Status	Documents
Jul 22, 1969	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
MatulaneEQ 50MG BASE · capsule;oral	Procarbazine Hydrochloride	RxReference drug

All 24 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 30, 2026	Supplement 44Labeling · Standard review	Approved	Label Letter
Feb 2, 2016	Supplement 39Manufacturing · Priority review	Approved	None posted
Dec 20, 2002	Supplement 35Labeling · Standard review	Approved	None posted
Mar 13, 2002	Supplement 34Manufacturing · Priority review	Approved	None posted
Nov 13, 2001	Supplement 33Manufacturing · Priority review	Approved	None posted
Mar 2, 2001	Supplement 32Manufacturing · Priority review	Approved	None posted
Mar 8, 1999	Supplement 31Manufacturing · Priority review	Approved	None posted
Oct 16, 1998	Supplement 30Manufacturing · Priority review	Approved	None posted
Aug 17, 1987	Supplement 26Labeling	Approved	None posted
Apr 9, 1987	Supplement 29Labeling	Approved	None posted
Mar 5, 1987	Supplement 27Manufacturing · Priority review	Approved	None posted
May 7, 1986	Supplement 28Labeling	Approved	None posted
Apr 29, 1986	Supplement 24Labeling	Approved	None posted
Dec 18, 1981	Supplement 23Manufacturing · Priority review	Approved	None posted
Aug 11, 1981	Supplement 19Labeling	Approved	None posted
Mar 31, 1981	Supplement 22Manufacturing · Priority review	Approved	None posted
Jul 24, 1980	Supplement 21Manufacturing · Priority review	Approved	None posted
Mar 24, 1980	Supplement 18Labeling	Approved	None posted
Nov 14, 1979	Supplement 20Manufacturing · Priority review	Approved	None posted
Jan 9, 1979	Supplement 17Manufacturing · Priority review	Approved	None posted
Nov 27, 1978	Supplement 16Manufacturing · Priority review	Approved	None posted
May 16, 1977	Supplement 14Manufacturing · Priority review	Approved	None posted
Apr 8, 1976	Supplement 13Manufacturing · Priority review	Approved	None posted
Jul 22, 1969	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 16785
Drugs@FDA: Overview at FDA
Company: Leadiant Biosciences

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters