APPLICATION
NDA018102
TYPE
NDA
ORIGINAL APPROVAL
1977-12-21
LATEST ACTION
1982-11-19
ROUTE
RECTAL
DOSAGE FORM
ENEMA
MARKETING STATUS
Discontinued
Products
MEDROLDiscontinued
METHYLPREDNISOLONE ACETATE 40MG/BOT · ENEMA · RECTAL
Approval history
1982-11-19Manufacturing (CMC) · Supplement 4 · standardAP
1981-04-01Manufacturing (CMC) · Supplement 2 · standardAP
1977-12-21Type 2 - New Active Ingredient · 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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