APPLICATION
ANDA074303
TYPE
ANDA
ORIGINAL APPROVAL
1995-08-17
LATEST ACTION
1999-02-19
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PENTAMIDINE ISETHIONATEDiscontinued
PENTAMIDINE ISETHIONATE 300MG/VIAL · INJECTABLE · INJECTION
Approval history
1999-02-19Manufacturing (CMC) · Supplement 12AP
1999-02-02Manufacturing (CMC) · Supplement 11AP
1998-08-07Labeling · Supplement 8AP
1998-04-03Manufacturing (CMC) · Supplement 10AP
1997-04-25Manufacturing (CMC) · Supplement 7AP
1997-02-28Manufacturing (CMC) · Supplement 5AP
1997-01-22Manufacturing (CMC) · Supplement 9AP
1996-12-04Manufacturing (CMC) · Supplement 6AP
1996-11-27Manufacturing (CMC) · Supplement 3AP
1996-11-04Manufacturing (CMC) · Supplement 2AP
1996-08-14Labeling · Supplement 4AP
1996-04-01Manufacturing (CMC) · Supplement 1AP
1995-08-17OriginalAP
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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