APPLICATION
ANDA202691
TYPE
ANDA
ORIGINAL APPROVAL
2016-02-16
LATEST ACTION
2026-06-11
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-06-11Labeling · Supplement 9 · standardAP
2024-12-19Labeling · Supplement 6 · standardAP
2019-12-23Labeling · Supplement 1 · standardAP
2019-12-23Labeling · Supplement 2 · standardAP
2016-02-16UNKNOWN · OriginalAP
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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