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FDA NDA · NDA011641

DIABINESE

Sponsor: PFIZER

APPLICATION
NDA011641
TYPE
NDA
ORIGINAL APPROVAL
1958-10-28
LATEST ACTION
2011-02-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

DIABINESE · ReferenceDiscontinued
CHLORPROPAMIDE 250MG · TABLET · ORAL
DIABINESE · ReferenceDiscontinued
CHLORPROPAMIDE 100MG · TABLET · ORAL

Approval history

2011-02-01Labeling · Supplement 66 · standard — Label ↗AP
2009-08-27Labeling · Supplement 65 · standard — Label ↗AP
2008-10-27Labeling · Supplement 64 · standard — Letter ↗AP
2004-01-04Labeling · Supplement 61 · standard — Review ↗AP
2002-05-16Labeling · Supplement 58 · standard — Review ↗AP
2002-05-16Labeling · Supplement 60 · standard — Letter ↗AP
1999-12-15Manufacturing (CMC) · Supplement 59 · priorityAP
1993-11-24Manufacturing (CMC) · Supplement 57 · priorityAP
1993-01-28Manufacturing (CMC) · Supplement 56 · priorityAP
1987-05-12Labeling · Supplement 55AP
1987-02-24Manufacturing (CMC) · Supplement 54 · priorityAP
1984-10-18Labeling · Supplement 50AP
1984-09-04Manufacturing (CMC) · Supplement 53 · priorityAP
1984-09-04Manufacturing (CMC) · Supplement 51 · priorityAP
1984-09-04Manufacturing (CMC) · Supplement 52 · priorityAP
1982-05-28Manufacturing (CMC) · Supplement 49 · priorityAP
1981-03-03Manufacturing (CMC) · Supplement 47 · priorityAP
1978-05-16Manufacturing (CMC) · Supplement 43 · priorityAP
1978-02-24Labeling · Supplement 44AP
1958-10-28Type 1 - New Molecular Entity · Original · priorityAP
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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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