← FDA DRUG APPROVALS

FDA NDA · NDA018045

EMCYT

Sponsor: PHARMACIA AND UPJOHN

APPLICATION
NDA018045
TYPE
NDA
ORIGINAL APPROVAL
1981-12-24
LATEST ACTION
2013-02-14
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

EMCYT · ReferenceDiscontinued
ESTRAMUSTINE PHOSPHATE SODIUM EQ 140MG PHOSPHATE · CAPSULE · ORAL

Approval history

2013-02-14Manufacturing (CMC) · Supplement 28 · standardAP
2008-07-09Labeling · Supplement 23 · standard — Letter ↗AP
2003-10-28Labeling · Supplement 21 · standard — Letter ↗AP
2002-01-18Labeling · Supplement 16 · standard — Letter ↗AP
2001-09-07Manufacturing (CMC) · Supplement 20 · standardAP
1999-02-10Manufacturing (CMC) · Supplement 18 · standardAP
1999-02-10Manufacturing (CMC) · Supplement 19 · standardAP
1998-10-15Manufacturing (CMC) · Supplement 17 · standardAP
1998-10-09Labeling · Supplement 10 · standardAP
1996-01-11Manufacturing (CMC) · Supplement 15 · standardAP
1995-10-05Manufacturing (CMC) · Supplement 8 · standardAP
1995-03-16Manufacturing (CMC) · Supplement 14 · standardAP
1994-03-16Manufacturing (CMC) · Supplement 7 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 9 · standardAP
1994-01-25Manufacturing (CMC) · Supplement 11 · standardAP
1993-04-28Manufacturing (CMC) · Supplement 6 · standardAP
1987-08-17Labeling · Supplement 5AP
1986-04-25Manufacturing (CMC) · Supplement 3 · standardAP
1984-10-22Labeling · Supplement 4AP
1982-06-30Manufacturing (CMC) · Supplement 1 · standardAP
1981-12-24Type 1 - New Molecular Entity · Original · standardAP
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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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