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FDA NDA · NDA020571

CAMPTOSAR

irinotecan hydrochloride

Sponsor: PFIZER INC

APPLICATION
NDA020571
TYPE
NDA
ORIGINAL APPROVAL
1996-06-14
LATEST ACTION
2024-04-04
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

CAMPTOSAR · ReferencePrescription
IRINOTECAN HYDROCHLORIDE 300MG/15ML (20MG/ML) · INJECTABLE · INJECTION
CAMPTOSAR · ReferencePrescription
IRINOTECAN HYDROCHLORIDE 40MG/2ML (20MG/ML) · INJECTABLE · INJECTION
CAMPTOSAR · ReferencePrescription
IRINOTECAN HYDROCHLORIDE 100MG/5ML (20MG/ML) · INJECTABLE · INJECTION

Approval history

2024-04-04Manufacturing (CMC) · Supplement 56 — Label ↗AP
2022-01-27Labeling · Supplement 53 · standard — Letter ↗AP
2022-01-27Labeling · Supplement 52 · standardAP
2020-01-30Labeling · Supplement 51 · standard — Letter ↗AP
2019-02-22Labeling · Supplement 50 · standard — Label ↗AP
2014-12-19Labeling · Supplement 48 · standard — Label ↗AP
2014-06-09Manufacturing (CMC) · Supplement 47 · priorityAP
2013-01-17Manufacturing (CMC) · Supplement 44 · priorityAP
2012-07-13Labeling · Supplement 42 · standard — Letter ↗AP
2010-05-14Labeling · Supplement 37 · unknown — Label ↗AP
2010-05-14Labeling · Supplement 33 · standard — Letter ↗AP
2010-05-14Labeling · Supplement 31 · standard — Label ↗AP
2010-05-14Labeling · Supplement 36 · standard — Letter ↗AP
2010-05-14Labeling · Supplement 32 · standard — Label ↗AP
2006-08-01Labeling · Supplement 30 · standard — Letter ↗AP
2005-07-21Labeling · Supplement 27 · standard — Letter ↗AP
2005-07-21Labeling · Supplement 28 · standard — Label ↗AP
2005-07-21Labeling · Supplement 24 · standard — Letter ↗AP
2005-06-07Labeling · Supplement 26 · standard — Label ↗AP
2004-12-03Labeling · Supplement 23 · standard — Letter ↗AP
2004-06-24Efficacy · Supplement 21 · priority — Pediatric Written Request ↗AP
2002-07-30Manufacturing (CMC) · Supplement 17 · priorityAP
2002-05-16Labeling · Supplement 16 · standard — Label ↗AP
2001-11-05Manufacturing (CMC) · Supplement 14 · priorityAP
2001-08-06Manufacturing (CMC) · Supplement 13 · priorityAP
2000-07-29Manufacturing (CMC) · Supplement 11 · priorityAP
2000-04-20Efficacy · Supplement 9 · priority — Review ↗AP
1998-10-22Efficacy · Supplement 8 · priority — Review ↗AP
1998-03-18Labeling · Supplement 7 · standard — Review ↗AP
1998-01-15Manufacturing (CMC) · Supplement 6 · priority — Review ↗AP
1997-12-10Manufacturing (CMC) · Supplement 2 · priorityAP
1997-10-21Manufacturing (CMC) · Supplement 5 · priorityAP
1997-06-05Manufacturing (CMC) · Supplement 3 · priorityAP
1997-03-07Labeling · Supplement 4 · standardAP
1997-01-03Labeling · Supplement 1 · standardAP
1996-06-14Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

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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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