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FDA ANDA · ANDA040612
METHYLPREDNISOLONE SODIUM SUCCINATE
Sponsor: FRESENIUS KABI USA
APPLICATION
ANDA040612
TYPE
ANDA
ORIGINAL APPROVAL
2004-08-12
LATEST ACTION
2025-07-03
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE SODIUM SUCCINATEPrescription
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
Approval history
2025-07-03Labeling · Supplement 17 · standardAP
2025-07-03Labeling · Supplement 15 · standardAP
2023-02-07Labeling · Supplement 12 · standardAP
2020-08-06Labeling · Supplement 8 · standardAP
2015-04-13Labeling · Supplement 5 · standardAP
2015-04-13Labeling · Supplement 6 · 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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