← FDA DRUG APPROVALS

FDA NDA · NDA020122

NIPENT

pentostatin

Sponsor: HOSPIRA INC

APPLICATION
NDA020122
TYPE
NDA
ORIGINAL APPROVAL
1991-10-11
LATEST ACTION
2025-11-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

NIPENT · ReferencePrescription
PENTOSTATIN 10MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-11-03Labeling · Supplement 21 · standard — Label ↗AP
2019-10-28Labeling · Supplement 15 · standard — Letter ↗AP
2015-12-29Manufacturing (CMC) · Supplement 13 · priorityAP
2013-06-20Manufacturing (CMC) · Supplement 12 · priorityAP
2009-09-22Manufacturing (CMC) · Supplement 10AP
2002-05-23Manufacturing (CMC) · Supplement 7 · priorityAP
2001-08-02Manufacturing (CMC) · Supplement 6 · priorityAP
1998-10-08Manufacturing (CMC) · Supplement 4 · priorityAP
1997-12-24Manufacturing (CMC) · Supplement 3 · priorityAP
1994-07-19Labeling · Supplement 2 · standardAP
1993-09-29Efficacy · Supplement 1 · unknownAP
1991-10-11Type 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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