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FDA ANDA · ANDA040287

PREDNISOLONE

Sponsor: IVAX SUB TEVA PHARMS

APPLICATION
ANDA040287
TYPE
ANDA
ORIGINAL APPROVAL
1999-05-28
LATEST ACTION
2002-11-08
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

PREDNISOLONEDiscontinued
PREDNISOLONE 15MG/5ML · SOLUTION · ORAL

Approval history

2002-11-08Manufacturing (CMC) · Supplement 7AP
2002-11-08Manufacturing (CMC) · Supplement 8AP
2002-02-08Manufacturing (CMC) · Supplement 6AP
2001-11-02Manufacturing (CMC) · Supplement 5AP
2000-12-18Manufacturing (CMC) · Supplement 3AP
2000-12-18Manufacturing (CMC) · Supplement 1AP
2000-12-18Manufacturing (CMC) · Supplement 4AP
2000-12-18Manufacturing (CMC) · Supplement 2AP
1999-05-28OriginalLabelAP
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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