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FDA ANDA · ANDA061639

E.E.S. 200

Sponsor: ARBOR PHARMS LLC

APPLICATION
ANDA061639
TYPE
ANDA
ORIGINAL APPROVAL
1973-10-15
LATEST ACTION
2015-09-01
ROUTE
ORAL
DOSAGE FORM
SUSPENSION
MARKETING STATUS
Discontinued

Products

E.E.S. 200Discontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL
E.E.S. 400Discontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 400MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SUSPENSION · ORAL

Approval history

2015-09-01Labeling · Supplement 33 · standardAP
2013-10-31Labeling · Supplement 32 · standardLabelAP
2009-02-25Labeling · Supplement 29AP
2009-02-25Labeling · Supplement 28AP
2006-07-21Labeling · Supplement 26AP
2001-01-17Labeling · Supplement 23AP
2000-11-16Labeling · Supplement 22AP
1997-11-28Manufacturing (CMC) · Supplement 21AP
1991-09-26Manufacturing (CMC) · Supplement 19AP
1973-10-15OriginalAP
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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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