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FDA ANDA · ANDA062256

ERYTHROMYCIN ETHYLSUCCINATE

Sponsor: BARR

APPLICATION
ANDA062256
TYPE
ANDA
ORIGINAL APPROVAL
1980-04-28
LATEST ACTION
2001-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ERYTHROMYCIN ETHYLSUCCINATEDiscontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE · TABLET · ORAL

Approval history

2001-06-01Labeling · Supplement 34AP
2001-02-14Labeling · Supplement 33AP
1998-12-01Manufacturing (CMC) · Supplement 31AP
1998-10-08Labeling · Supplement 32AP
1994-12-23Manufacturing (CMC) · Supplement 30AP
1994-10-11Manufacturing (CMC) · Supplement 29AP
1993-07-01Labeling · Supplement 28AP
1992-04-03Manufacturing (CMC) · Supplement 27AP
1992-04-03Manufacturing (CMC) · Supplement 25AP
1992-02-25Labeling · Supplement 23AP
1992-01-13Labeling · Supplement 24AP
1989-03-28Manufacturing (CMC) · Supplement 22AP
1980-04-28OriginalAP
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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