APPLICATION
ANDA040557
TYPE
ANDA
ORIGINAL APPROVAL
2005-02-23
LATEST ACTION
2022-07-06
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 40MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 80MG/ML · INJECTABLE · INJECTION
Approval history
2022-07-06Labeling · Supplement 34 · standardAP
2020-08-07Labeling · Supplement 30 · standardAP
2020-08-07Labeling · Supplement 27 · standardAP
2012-01-03Labeling · Supplement 16AP
2010-12-01Labeling · Supplement 3AP
2005-02-23OriginalAP
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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