APPLICATION
ANDA073479
TYPE
ANDA
ORIGINAL APPROVAL
1992-06-30
LATEST ACTION
2002-04-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
PENTAMIDINE ISETHIONATEDiscontinued
PENTAMIDINE ISETHIONATE 300MG/VIAL · INJECTABLE · INJECTION
Approval history
2002-04-10Manufacturing (CMC) · Supplement 9AP
2002-03-12Manufacturing (CMC) · Supplement 10AP
1999-05-27Labeling · Supplement 8AP
1998-12-09Manufacturing (CMC) · Supplement 7AP
1996-11-20Labeling · Supplement 4AP
1995-06-12Manufacturing (CMC) · Supplement 3AP
1993-07-15Labeling · Supplement 2AP
1993-06-01Manufacturing (CMC) · Supplement 1AP
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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