← FDA DRUG APPROVALS

FDA NDA · NDA020637

GLIADEL

carmustine

Sponsor: AZURITY

APPLICATION
NDA020637
TYPE
NDA
ORIGINAL APPROVAL
1996-09-23
LATEST ACTION
2018-12-05
ROUTE
INTRACAVITARY, INTRACRANIAL
DOSAGE FORM
IMPLANT
MARKETING STATUS
Prescription

Products

GLIADEL · ReferencePrescription
CARMUSTINE 7.7MG · IMPLANT · INTRACRANIAL

Approval history

2018-12-05Labeling · Supplement 29 · standard — Letter ↗AP
2015-06-01Manufacturing (CMC) · Supplement 28 · priorityAP
2014-11-20Labeling · Supplement 27 · standard — Letter ↗AP
2013-08-16Labeling · Supplement 26 · standard — Letter ↗AP
2006-12-26Labeling · Supplement 22 · standard — Letter ↗AP
2003-02-25Efficacy · Supplement 16 · priority — Review ↗AP
2001-11-07Manufacturing (CMC) · Supplement 17 · priorityAP
2001-05-15Manufacturing (CMC) · Supplement 15 · priorityAP
2000-09-27Manufacturing (CMC) · Supplement 11 · priorityAP
2000-08-08Manufacturing (CMC) · Supplement 14 · priorityAP
1999-10-25Manufacturing (CMC) · Supplement 13 · priorityAP
1999-07-16Manufacturing (CMC) · Supplement 12 · priorityAP
1999-03-25Manufacturing (CMC) · Supplement 10 · priorityAP
1999-02-10Manufacturing (CMC) · Supplement 9 · priorityAP
1998-10-16Manufacturing (CMC) · Supplement 8 · priorityAP
1998-02-12Manufacturing (CMC) · Supplement 7 · priorityAP
1998-01-22Manufacturing (CMC) · Supplement 6 · priorityAP
1997-09-15Manufacturing (CMC) · Supplement 3 · priorityAP
1997-08-22Manufacturing (CMC) · Supplement 4 · priorityAP
1997-04-04Manufacturing (CMC) · Supplement 2 · priorityAP
1996-10-08Manufacturing (CMC) · Supplement 1 · priorityAP
1996-09-23Type 3 - New Dosage Form · Original · priority — Review ↗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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