← FDA DRUG APPROVALS

FDA NDA · NDA050629

DOXORUBICIN HYDROCHLORIDE

Sponsor: PFIZER

APPLICATION
NDA050629
TYPE
NDA
ORIGINAL APPROVAL
1987-12-23
LATEST ACTION
2024-05-09
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

DOXORUBICIN HYDROCHLORIDE · ReferencePrescription
DOXORUBICIN HYDROCHLORIDE 200MG/100ML · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDE · ReferenceDiscontinued
DOXORUBICIN HYDROCHLORIDE 150MG/75ML · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDE · ReferencePrescription
DOXORUBICIN HYDROCHLORIDE 2MG/ML · INJECTABLE · INJECTION

Approval history

2024-05-09Manufacturing (CMC) · Supplement 33 — Label ↗AP
2020-08-28Labeling · Supplement 30 · standard — Letter ↗AP
2019-12-20Labeling · Supplement 28 · standard — Label ↗AP
2019-08-09Labeling · Supplement 29 · standard — Label ↗AP
2014-12-05Manufacturing (CMC) · Supplement 25 · priorityAP
2013-10-31Labeling · Supplement 22 · standard — Letter ↗AP
2013-10-23Manufacturing (CMC) · Supplement 24 · priorityAP
2013-10-10Manufacturing (CMC) · Supplement 23 · priorityAP
2011-09-26Labeling · Supplement 19 · unknown — Letter ↗AP
2011-03-28Manufacturing (CMC) · Supplement 18AP
2010-07-30Labeling · Supplement 17 · unknown — Letter ↗AP
2003-05-08Labeling · Supplement 16 · standard — Label ↗AP
2003-05-08Efficacy · Supplement 14 · standard — Letter ↗AP
2002-09-25Labeling · Supplement 10 · standard — Letter ↗AP
2002-09-25Labeling · Supplement 13 · standard — Letter ↗AP
2002-04-02Manufacturing (CMC) · Supplement 12 · priorityAP
2002-01-10Manufacturing (CMC) · Supplement 11 · priorityAP
2000-08-10Manufacturing (CMC) · Supplement 8 · priorityAP
2000-08-10Manufacturing (CMC) · Supplement 9 · priorityAP
1999-03-04Labeling · Supplement 7 · standardAP
1998-02-13Labeling · Supplement 6 · standardAP
1997-09-15Manufacturing (CMC) · Supplement 5 · priorityAP
1997-09-05Manufacturing (CMC) · Supplement 4 · priorityAP
1996-05-03Manufacturing (CMC) · Supplement 3 · priorityAP
1994-11-29Labeling · Supplement 2AP
1987-12-23Type 3 - New Dosage Form · 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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