← FDA DRUG APPROVALS

FDA NDA · NDA017588

GLEOSTINE

lomustine

Sponsor: AZURITY

APPLICATION
NDA017588
TYPE
NDA
ORIGINAL APPROVAL
1976-08-04
LATEST ACTION
2020-06-04
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription, Discontinued

Products

GLEOSTINE · ReferencePrescription
LOMUSTINE 40MG · CAPSULE · ORAL
GLEOSTINE · ReferencePrescription
LOMUSTINE 100MG · CAPSULE · ORAL
GLEOSTINE · ReferencePrescription
LOMUSTINE 10MG · CAPSULE · ORAL
GLEOSTINE · ReferenceDiscontinued
LOMUSTINE 5MG · CAPSULE · ORAL

Approval history

2020-06-04Manufacturing (CMC) · Supplement 46 — Letter ↗AP
2016-01-29Labeling · Supplement 43 · standard — Letter ↗AP
2016-01-06Labeling · Supplement 42 · standard — Letter ↗AP
2015-01-05Manufacturing (CMC) · Supplement 41 · standardAP
2014-05-20Labeling · Supplement 40 · standard — Letter ↗AP
2013-08-15Labeling · Supplement 39 · standard — Label ↗AP
2013-08-14Manufacturing (CMC) · Supplement 38 · standardAP
2012-11-21Labeling · Supplement 36 · standard — Letter ↗AP
2011-05-12Labeling · Supplement 37 · standard — Letter ↗AP
2009-04-30Labeling · Supplement 34 · standard — Letter ↗AP
2003-02-27Labeling · Supplement 33 · standard — Letter ↗AP
2002-12-20Labeling · Supplement 31 · standard — Letter ↗AP
1999-06-01Manufacturing (CMC) · Supplement 32 · standardAP
1993-03-02Manufacturing (CMC) · Supplement 30 · standardAP
1991-03-14Manufacturing (CMC) · Supplement 27 · standardAP
1990-08-01Manufacturing (CMC) · Supplement 29 · standardAP
1988-11-14Manufacturing (CMC) · Supplement 28 · standardAP
1988-07-05Manufacturing (CMC) · Supplement 26 · standardAP
1987-08-26Manufacturing (CMC) · Supplement 25 · standardAP
1986-10-14Labeling · Supplement 11AP
1986-09-22Labeling · Supplement 22AP
1986-09-22Labeling · Supplement 20AP
1986-09-12Manufacturing (CMC) · Supplement 24 · standardAP
1986-09-12Manufacturing (CMC) · Supplement 23 · standardAP
1985-06-18Manufacturing (CMC) · Supplement 19 · standardAP
1985-03-06Manufacturing (CMC) · Supplement 17 · standardAP
1983-07-22Labeling · Supplement 12AP
1983-06-28Labeling · Supplement 15AP
1982-02-16Labeling · Supplement 10AP
1980-11-12Manufacturing (CMC) · Supplement 9 · standardAP
1980-11-12Labeling · Supplement 8AP
1980-09-19Manufacturing (CMC) · Supplement 5 · standardAP
1980-08-07Manufacturing (CMC) · Supplement 7 · standardAP
1978-11-14Labeling · Supplement 4AP
1977-04-22Manufacturing (CMC) · Supplement 2 · standardAP
1976-08-04Type 1 - New Molecular Entity · Original · standardAP
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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