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FDA NDA · NDA050778

ELLENCE

epirubicin hydrochloride

Sponsor: PFIZER INC

APPLICATION
NDA050778
TYPE
NDA
ORIGINAL APPROVAL
1999-09-15
LATEST ACTION
2024-11-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ELLENCE · ReferencePrescription
EPIRUBICIN HYDROCHLORIDE 200MG/100ML (2MG/ML) · INJECTABLE · INJECTION
ELLENCE · ReferencePrescription
EPIRUBICIN HYDROCHLORIDE 50MG/25ML (2MG/ML) · INJECTABLE · INJECTION

Approval history

2024-11-25Manufacturing (CMC) · Supplement 29 — Label ↗AP
2021-02-18Labeling · Supplement 26 · standard — Letter ↗AP
2019-07-26Labeling · Supplement 25 · standard — Label ↗AP
2019-07-26Labeling · Supplement 24 · standard — Label ↗AP
2014-12-15Labeling · Supplement 21 · standard — Letter ↗AP
2013-02-19Labeling · Supplement 19 · standard — Letter ↗AP
2011-09-14Labeling · Supplement 17 · unknown — Label ↗AP
2011-09-14Labeling · Supplement 15 · standard — Letter ↗AP
2011-09-14Labeling · Supplement 18 · standard — Label ↗AP
2005-03-02Efficacy · Supplement 8 · standard — Label ↗AP
2003-04-03Labeling · Supplement 3 · priority — Letter ↗AP
2003-04-03Labeling · Supplement 4 · standard — Letter ↗AP
2000-07-20Manufacturing (CMC) · Supplement 2 · priorityAP
1999-09-15Type 1 - New Molecular Entity · Original · priority — Label ↗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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