← FDA DRUG APPROVALS

FDA NDA · NDA017422

CARMUSTINE

Sponsor: AVET LIFESCIENCES

APPLICATION
NDA017422
TYPE
NDA
ORIGINAL APPROVAL
1977-03-07
LATEST ACTION
2021-04-30
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

BICNU · ReferencePrescription
CARMUSTINE 100MG/VIAL · INJECTABLE · INJECTION

Approval history

2021-04-30Manufacturing (CMC) · Supplement 62 — Letter ↗AP
2017-03-24Labeling · Supplement 55 · standard — Label ↗AP
2016-04-28Labeling · Supplement 50 · standard — Letter ↗AP
2015-11-25Manufacturing (CMC) · Supplement 49 · standardAP
2014-06-13Manufacturing (CMC) · Supplement 47 · standard — Review ↗AP
2013-10-18Labeling · Supplement 46 · standard — Label ↗AP
2013-09-18Manufacturing (CMC) · Supplement 45 · standard — Review ↗AP
2011-08-11Labeling · Supplement 42 · standard — Letter ↗AP
2011-03-14Labeling · Supplement 38 · standard — Letter ↗AP
2007-08-17Manufacturing (CMC) · Supplement 37 — Label ↗AP
2005-10-20Manufacturing (CMC) · Supplement 36 · standard — Letter ↗AP
2003-02-27Labeling · Supplement 35 · standard — Letter ↗AP
1997-09-10Labeling · Supplement 34 · standardAP
1992-12-11Labeling · Supplement 31AP
1992-07-13Manufacturing (CMC) · Supplement 32 · standardAP
1991-06-13Manufacturing (CMC) · Supplement 29 · standardAP
1991-01-03Manufacturing (CMC) · Supplement 28 · standardAP
1989-09-14Manufacturing (CMC) · Supplement 27 · standardAP
1989-04-19Manufacturing (CMC) · Supplement 25 · standardAP
1988-05-17Manufacturing (CMC) · Supplement 24 · standardAP
1988-01-12Manufacturing (CMC) · Supplement 23 · standardAP
1987-10-26Labeling · Supplement 22AP
1987-08-07Manufacturing (CMC) · Supplement 20 · standardAP
1987-04-21Labeling · Supplement 8AP
1987-03-05Manufacturing (CMC) · Supplement 19 · standardAP
1986-07-11Labeling · Supplement 15AP
1986-05-19Labeling · Supplement 17AP
1986-05-19Labeling · Supplement 18AP
1986-05-19Labeling · Supplement 16AP
1984-12-10Manufacturing (CMC) · Supplement 14 · standardAP
1984-08-08Manufacturing (CMC) · Supplement 13 · standardAP
1984-04-03Manufacturing (CMC) · Supplement 6 · standardAP
1984-03-13Manufacturing (CMC) · Supplement 12 · standardAP
1984-02-17Manufacturing (CMC) · Supplement 10 · standardAP
1983-06-29Labeling · Supplement 11AP
1983-02-10Manufacturing (CMC) · Supplement 9 · standardAP
1982-02-16Labeling · Supplement 7AP
1980-11-12Labeling · Supplement 5AP
1979-10-09Manufacturing (CMC) · Supplement 3 · standardAP
1979-10-09Labeling · Supplement 4AP
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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