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FDA ANDA · ANDA040719

METHYLPREDNISOLONE ACETATE

Sponsor: SANDOZ

APPLICATION
ANDA040719
TYPE
ANDA
ORIGINAL APPROVAL
2009-01-29
LATEST ACTION
2026-04-10
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 40MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 80MG/ML · INJECTABLE · INJECTION

Approval history

2026-04-10Labeling · Supplement 9 · standardAP
2025-02-12Labeling · Supplement 8 · standardAP
2025-02-12Labeling · Supplement 7 · standardAP
2014-04-21Labeling · Supplement 5 · standardAP
2009-01-29Original — Review ↗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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