APPLICATION
ANDA207667
TYPE
ANDA
ORIGINAL APPROVAL
2015-12-15
LATEST ACTION
2024-11-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
METHYLPREDNISOLONE SODIUM SUCCINATEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 2GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 125MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONE SODIUM SUCCINATEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 40MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2024-11-13Labeling · Supplement 5 · standardAP
2024-11-13Labeling · Supplement 3 · standardAP
2020-04-02Labeling · Supplement 2 · standardAP
2020-04-02Labeling · Supplement 1 · standardAP
2015-12-15UNKNOWN · Original · 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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