← FDA DRUG APPROVALS

FDA NDA · NDA050609

ERYTHROCIN LACTOBIONATE

erythromycin lactobionate

Sponsor: HOSPIRA

APPLICATION
NDA050609
TYPE
NDA
ORIGINAL APPROVAL
1986-09-24
LATEST ACTION
2022-11-18
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ERYTHROCIN · ReferencePrescription
ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
ERYTHROCIN · ReferenceDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

2022-11-18Labeling · Supplement 51 · standard — Label ↗AP
2019-11-05Labeling · Supplement 41 · standard — Letter ↗AP
2018-04-23Labeling · Supplement 39 · standard — Label ↗AP
2015-10-27Manufacturing (CMC) · Supplement 36 · standardAP
2015-04-22Manufacturing (CMC) · Supplement 35 · standardAP
2013-08-19Labeling · Supplement 34 · standard — Letter ↗AP
2012-02-02Labeling · Supplement 33 · standard — Letter ↗AP
2011-06-09Labeling · Supplement 32 · standard — Letter ↗AP
2008-02-26Labeling · Supplement 25 · standard — Letter ↗AP
2004-09-16Labeling · Supplement 19 · standard — Letter ↗AP
2002-12-13Manufacturing (CMC) · Supplement 18 · standardAP
2002-08-29Manufacturing (CMC) · Supplement 17 · standardAP
2002-05-23Labeling · Supplement 15 · standard — Letter ↗AP
2001-03-20Manufacturing (CMC) · Supplement 16 · standardAP
1999-11-08Manufacturing (CMC) · Supplement 14 · standardAP
1997-10-27Manufacturing (CMC) · Supplement 11 · standardAP
1996-03-18Manufacturing (CMC) · Supplement 10 · standardAP
1994-08-24Labeling · Supplement 8AP
1994-08-24Labeling · Supplement 7AP
1993-03-12Labeling · Supplement 9AP
1991-12-05Manufacturing (CMC) · Supplement 6 · standardAP
1987-09-21Labeling · Supplement 2AP
1986-09-24Type 3 - New Dosage Form · Original · standardAP
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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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