APPLICATION
ANDA214870
TYPE
ANDA
ORIGINAL APPROVAL
2023-01-03
LATEST ACTION
2024-06-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 80MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 40MG/ML · INJECTABLE · INJECTION
Approval history
2024-06-03Labeling · Supplement 6 · standardAP
2023-05-10Manufacturing (CMC) · Supplement 1 · unknownAP
2023-01-03UNKNOWN · 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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