APPLICATION
NDA050182
TYPE
NDA
ORIGINAL APPROVAL
1964-06-25
LATEST ACTION
2004-09-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ERYTHROCINDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
ERYTHROCINDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2002-12-13Manufacturing (CMC) · Supplement 124AP
2002-08-29Manufacturing (CMC) · Supplement 123AP
1999-04-23Manufacturing (CMC) · Supplement 121AP
1997-10-27Manufacturing (CMC) · Supplement 119AP
1996-10-11Labeling · Supplement 27AP
1996-03-18Manufacturing (CMC) · Supplement 118AP
1993-03-12Labeling · Supplement 28AP
1991-12-05Manufacturing (CMC) · Supplement 26AP
1991-05-03Labeling · Supplement 23AP
1988-11-30Manufacturing (CMC) · Supplement 22AP
1987-12-30Labeling · Supplement 21AP
1984-09-25Manufacturing (CMC) · Supplement 13AP
1984-05-16Manufacturing (CMC) · Supplement 14AP
1983-12-20Manufacturing (CMC) · Supplement 12AP
1983-11-09Labeling · Supplement 11AP
1983-11-01Labeling · Supplement 10AP
1983-10-06Manufacturing (CMC) · Supplement 117AP
1983-07-22Manufacturing (CMC) · Supplement 9AP
1983-06-02Manufacturing (CMC) · Supplement 8AP
1983-05-27Manufacturing (CMC) · Supplement 7AP
1982-10-08Manufacturing (CMC) · Supplement 2AP
1982-09-23Manufacturing (CMC) · Supplement 116AP
1982-05-21Manufacturing (CMC) · Supplement 115AP
1982-04-06Manufacturing (CMC) · Supplement 114AP
1981-11-10Manufacturing (CMC) · Supplement 113AP
1981-10-07Labeling · Supplement 112AP
1981-09-16Manufacturing (CMC) · Supplement 111AP
1981-06-05Manufacturing (CMC) · Supplement 110AP
1981-05-20Manufacturing (CMC) · Supplement 109AP
1981-05-14Manufacturing (CMC) · Supplement 108AP
1981-04-28Manufacturing (CMC) · Supplement 107AP
1981-03-03Manufacturing (CMC) · Supplement 106AP
1981-01-30Labeling · Supplement 105AP
1980-12-17Labeling · Supplement 104AP
1980-10-21Labeling · Supplement 101AP
1980-10-21Labeling · Supplement 102AP
1980-09-23Manufacturing (CMC) · Supplement 100AP
1980-09-04Manufacturing (CMC) · Supplement 99AP
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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