APPLICATION
ANDA062638
TYPE
ANDA
ORIGINAL APPROVAL
1986-10-31
LATEST ACTION
2021-07-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
ERYTHROCINPrescription
ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
ERYTHROCINDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2021-07-16Labeling · Supplement 40 · standardAP
2021-07-16Labeling · Supplement 33 · standardAP
2015-09-21Labeling · Supplement 30 · standardAP
2015-09-21Labeling · Supplement 31 · standardAP
2004-07-21Labeling · Supplement 20AP
2002-09-11Manufacturing (CMC) · Supplement 19AP
2001-04-09Manufacturing (CMC) · Supplement 18AP
1998-10-16Manufacturing (CMC) · Supplement 17AP
1996-05-10Labeling · Supplement 8AP
1996-05-10Labeling · Supplement 6AP
1996-05-10Labeling · Supplement 12AP
1996-05-10Labeling · Supplement 7AP
1995-05-22Manufacturing (CMC) · Supplement 14AP
1995-05-22Manufacturing (CMC) · Supplement 15AP
1995-05-10Manufacturing (CMC) · Supplement 13AP
1994-10-14Manufacturing (CMC) · Supplement 11AP
1992-10-30Manufacturing (CMC) · Supplement 10AP
1992-04-28Manufacturing (CMC) · Supplement 9AP
1991-09-26Manufacturing (CMC) · Supplement 5AP
1988-11-30Manufacturing (CMC) · Supplement 3AP
1986-10-31OriginalAP
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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