APPLICATION
ANDA201835
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-27
LATEST ACTION
2023-12-12
ROUTE
INTRA-ARTICULAR, INTRALESIONAL, INTRAMUSCULAR, INTRASYNOVIAL, SOFT TISSUE, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued
Products
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 80MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEDiscontinued
METHYLPREDNISOLONE ACETATE 20MG/ML · INJECTABLE · INJECTION
METHYLPREDNISOLONE ACETATEPrescription
METHYLPREDNISOLONE ACETATE 40MG/ML · INJECTABLE · INJECTION
Approval history
2023-12-12Labeling · Supplement 5 · standardAP
2020-08-07Labeling · Supplement 1 · 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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