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FDA ANDA · ANDA075117

ORAPRED

Sponsor: CONCORDIA PHARMS INC

APPLICATION
ANDA075117
TYPE
ANDA
ORIGINAL APPROVAL
2000-12-14
LATEST ACTION
2005-06-16
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

ORAPREDDiscontinued
PREDNISOLONE SODIUM PHOSPHATE EQ 15MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · ORAL

Approval history

2005-06-16Labeling · Supplement 12AP
2002-11-07Manufacturing (CMC) · Supplement 6AP
2002-05-08Manufacturing (CMC) · Supplement 5AP
2001-08-28Manufacturing (CMC) · Supplement 3AP
2001-08-28Manufacturing (CMC) · Supplement 4AP
2001-06-25Manufacturing (CMC) · Supplement 2AP
2001-03-28Manufacturing (CMC) · Supplement 1AP
2000-12-14Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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