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FDA ANDA · ANDA062563

ERYTHROMYCIN

Sponsor: ELKINS SINN

APPLICATION
ANDA062563
TYPE
ANDA
ORIGINAL APPROVAL
1985-03-28
LATEST ACTION
1996-03-01
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ERYTHROMYCINDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
ERYTHROMYCINDiscontinued
ERYTHROMYCIN LACTOBIONATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION

Approval history

1996-03-01Labeling · Supplement 22AP
1995-09-18Manufacturing (CMC) · Supplement 21AP
1994-08-18Manufacturing (CMC) · Supplement 18AP
1994-03-23Manufacturing (CMC) · Supplement 19AP
1993-10-22Manufacturing (CMC) · Supplement 17AP
1993-03-01Labeling · Supplement 16AP
1992-04-22Labeling · Supplement 15AP
1992-03-18Manufacturing (CMC) · Supplement 14AP
1991-09-16Labeling · Supplement 13AP
1990-08-27Manufacturing (CMC) · Supplement 12AP
1985-03-28OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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