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FDA NDA · NDA050529

PEDIAZOLE

Sponsor: ROSS LABS

APPLICATION
NDA050529
TYPE
NDA
ORIGINAL APPROVAL
1979-11-29
LATEST ACTION
2004-02-09
ROUTE
ORAL
DOSAGE FORM
GRANULE
MARKETING STATUS
Discontinued

Products

PEDIAZOLEDiscontinued
ERYTHROMYCIN ETHYLSUCCINATE EQ 200MG BASE/5ML, SULFISOXAZOLE ACETYL EQ 600MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GRANULE · ORAL

Approval history

2004-02-09Labeling · Supplement 33 · standard — Letter ↗AP
1994-06-21Manufacturing (CMC) · Supplement 31 · standardAP
1993-05-06Manufacturing (CMC) · Supplement 30 · standardAP
1992-09-29Labeling · Supplement 21AP
1992-09-29Efficacy · Supplement 12AP
1992-03-11Manufacturing (CMC) · Supplement 29 · standardAP
1991-04-16Manufacturing (CMC) · Supplement 27 · standardAP
1979-11-29Type 3 - New Dosage Form and Type 4 - New Combination · Original · standardAP
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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