APPLICATION
NDA019264
TYPE
NDA
ORIGINAL APPROVAL
1984-10-16
LATEST ACTION
2014-01-08
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
PENTAM · ReferencePrescription
PENTAMIDINE ISETHIONATE 300MG/VIAL · INJECTABLE · INJECTION
Approval history
2014-01-08Manufacturing (CMC) · Supplement 32AP
2013-02-16Manufacturing (CMC) · Supplement 31AP
2002-05-24Manufacturing (CMC) · Supplement 23AP
1997-10-24Labeling · Supplement 21 · standardAP
1997-02-26Labeling · Supplement 19 · standardAP
1996-08-27Labeling · Supplement 15AP
1996-03-18Labeling · Supplement 18 · standardAP
1994-06-08Manufacturing (CMC) · Supplement 17AP
1994-05-31Manufacturing (CMC) · Supplement 16AP
1993-02-09Labeling · Supplement 13AP
1989-08-16Manufacturing (CMC) · Supplement 14AP
1988-11-14Manufacturing (CMC) · Supplement 12AP
1987-06-12Manufacturing (CMC) · Supplement 8AP
1987-06-10Manufacturing (CMC) · Supplement 3AP
1987-04-09Labeling · Supplement 4AP
1986-10-24Manufacturing (CMC) · Supplement 7AP
1986-10-24Manufacturing (CMC) · Supplement 5AP
1986-10-24Manufacturing (CMC) · Supplement 6AP
1985-08-06Manufacturing (CMC) · Supplement 2AP
1984-10-16Type 1 - New Molecular Entity · Original · priorityAP
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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