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FDA ANDA · ANDA207549
METHYLPREDNISOLONE SODIUM SUCCINATE
methylprednisolone
Sponsor: AMNEAL
APPLICATION
ANDA207549
TYPE
ANDA
ORIGINAL APPROVAL
2016-11-09
LATEST ACTION
2026-06-25
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-06-25Labeling · Supplement 21 · standardAP
2024-11-06Labeling · Supplement 18 · standardAP
2024-05-07Labeling · Supplement 16 · standardAP
2024-05-07Labeling · Supplement 12 · standardAP
2024-05-07Labeling · Supplement 17 · standardAP
2020-02-21Labeling · Supplement 3 · standardAP
2020-02-21Labeling · Supplement 4 · standardAP
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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