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FDA NDA · NDA050467

DOXORUBICIN HYDROCHLORIDE

Sponsor: PFIZER

APPLICATION
NDA050467
TYPE
NDA
ORIGINAL APPROVAL
1974-08-07
LATEST ACTION
2020-08-28
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 150MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 50MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 20MG/VIAL · INJECTABLE · INJECTION
DOXORUBICIN HYDROCHLORIDEDiscontinued
DOXORUBICIN HYDROCHLORIDE 10MG/VIAL · INJECTABLE · INJECTION

Approval history

2020-08-28Labeling · Supplement 78 · standard — Letter ↗AP
2019-12-20Labeling · Supplement 76 · standard — Label ↗AP
2019-08-09Labeling · Supplement 77 · standard — Label ↗AP
2015-09-10Manufacturing (CMC) · Supplement 75 · priorityAP
2013-10-31Labeling · Supplement 73 · standard — Letter ↗AP
2013-10-10Manufacturing (CMC) · Supplement 74 · priorityAP
2011-09-26Labeling · Supplement 71 · unknown — Label ↗AP
2010-07-30Labeling · Supplement 70 · unknown — Label ↗AP
2003-05-08Labeling · Supplement 69 · standard — Label ↗AP
2003-05-08Efficacy · Supplement 68 · standard — Label ↗AP
2002-09-25Labeling · Supplement 67 · standard — Label ↗AP
2002-09-25Labeling · Supplement 64 · standard — Label ↗AP
2002-04-02Manufacturing (CMC) · Supplement 66 · priorityAP
2002-01-10Manufacturing (CMC) · Supplement 65 · priorityAP
1999-03-04Labeling · Supplement 63 · standardAP
1998-02-13Labeling · Supplement 62 · standardAP
1997-10-14Manufacturing (CMC) · Supplement 61 · priorityAP
1996-05-03Manufacturing (CMC) · Supplement 60 · priorityAP
1995-04-26Manufacturing (CMC) · Supplement 59 · priorityAP
1994-11-29Labeling · Supplement 2AP
1988-03-25Manufacturing (CMC) · Supplement 57 · priorityAP
1987-12-30Manufacturing (CMC) · Supplement 56 · priorityAP
1987-07-22Labeling · Supplement 55AP
1987-07-22Manufacturing (CMC) · Supplement 54 · priorityAP
1987-04-28Labeling · Supplement 53AP
1987-03-27Labeling · Supplement 50AP
1987-03-25Manufacturing (CMC) · Supplement 49 · priorityAP
1987-03-25Manufacturing (CMC) · Supplement 48 · priorityAP
1987-02-19Labeling · Supplement 52AP
1986-11-06Manufacturing (CMC) · Supplement 47 · priorityAP
1986-05-21Manufacturing (CMC) · Supplement 46 · priorityAP
1986-03-21Labeling · Supplement 45AP
1986-02-11Labeling · Supplement 44AP
1985-06-07Manufacturing (CMC) · Supplement 42 · priorityAP
1985-05-20Labeling · Supplement 41AP
1985-03-04Manufacturing (CMC) · Supplement 40 · priorityAP
1985-01-16Manufacturing (CMC) · Supplement 39 · priorityAP
1983-08-25Manufacturing (CMC) · Supplement 37 · priorityAP
1983-08-10Labeling · Supplement 36AP
1983-02-24Labeling · Supplement 35AP
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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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