APPLICATION
ANDA040794
TYPE
ANDA
ORIGINAL APPROVAL
2009-03-05
LATEST ACTION
2026-01-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 80MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 40MG/ML · INJECTABLE · INJECTION
Approval history
2026-01-20Labeling · Supplement 7 · standardAP
2026-01-20Labeling · Supplement 8 · standardAP
2010-12-28Labeling · Supplement 3AP
2010-04-30Labeling · Supplement 2AP
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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