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FDA ANDA · ANDA087535

METHYLPREDNISOLONE

Sponsor: ORGANON USA INC

APPLICATION
ANDA087535
TYPE
ANDA
ORIGINAL APPROVAL
1982-06-25
LATEST ACTION
1985-04-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 1GM BASE/VIAL · INJECTABLE · INJECTION
METHYLPREDNISOLONEDiscontinued
METHYLPREDNISOLONE SODIUM SUCCINATE EQ 500MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

1985-04-12Manufacturing (CMC) · Supplement 5AP
1985-04-12Manufacturing (CMC) · Supplement 3AP
1983-02-28Manufacturing (CMC) · Supplement 1AP
1982-06-25OriginalAP
VIEW ON DRUGS@FDA ↗

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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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