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FDA ANDA · ANDA040584

PREDNISONE

Sponsor: PH HEALTH

APPLICATION
ANDA040584
TYPE
ANDA
ORIGINAL APPROVAL
2004-12-21
LATEST ACTION
2024-06-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

PREDNISONEPrescription
PREDNISONE 1MG · TABLET · ORAL

Approval history

2024-06-05Labeling · Supplement 22 · standardAP
2024-05-28Labeling · Supplement 12 · standardAP
2024-05-28Labeling · Supplement 5AP
2008-01-16Labeling · Supplement 2AP
2004-12-21OriginalAP
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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