← FDA DRUG APPROVALS

FDA NDA · NDA050611

PCE

Sponsor: AZURITY

APPLICATION
NDA050611
TYPE
NDA
ORIGINAL APPROVAL
1986-09-09
LATEST ACTION
2018-04-23
ROUTE
ORAL
DOSAGE FORM
TABLET, COATED PARTICLES
MARKETING STATUS
Discontinued

Products

PCE · ReferenceDiscontinued
ERYTHROMYCIN 333MG · TABLET, COATED PARTICLES · ORAL
PCE · ReferenceDiscontinued
ERYTHROMYCIN 500MG · TABLET, COATED PARTICLES · ORAL

Approval history

2018-04-23Labeling · Supplement 36 · standard — Label ↗AP
2012-02-02Labeling · Supplement 35 · standard — Label ↗AP
2011-01-27Labeling · Supplement 27 · standard — Label ↗AP
2010-11-04Labeling · Supplement 31 · standard — Letter ↗AP
2008-12-10Labeling · Supplement 32 · standard — Letter ↗AP
2008-05-22Labeling · Supplement 30 · standard — Letter ↗AP
2008-01-05Labeling · Supplement 29 · standard — Label ↗AP
2006-08-09Labeling · Supplement 22 · standard — Label ↗AP
2004-03-12Labeling · Supplement 24 · standard — Letter ↗AP
2002-04-25Labeling · Supplement 19 · standard — Letter ↗AP
2000-02-04Labeling · Supplement 18 · standard — Review ↗AP
1998-05-14Manufacturing (CMC) · Supplement 17 · standardAP
1997-04-14Labeling · Supplement 16 · standardAP
1993-05-18Labeling · Supplement 12AP
1990-08-22Manufacturing (CMC) · Supplement 11 · standardAP
1989-09-25Bioequivalence · Supplement 9 · standardAP
1989-09-25Bioequivalence · Supplement 1 · standardAP
1989-09-25Bioequivalence · Supplement 2 · standardAP
1988-01-05Labeling · Supplement 14AP
1987-10-08Manufacturing (CMC) · Supplement 5 · standardAP
1987-07-13Labeling · Supplement 6AP
1987-05-20Manufacturing (CMC) · Supplement 13 · standardAP
1987-05-15Manufacturing (CMC) · Supplement 4 · standardAP
1987-02-04Manufacturing (CMC) · Supplement 3 · standardAP
1986-09-09Type 3 - New Dosage Form · Original · standardAP
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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