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FDA ANDA · ANDA086619

HYDROCORTISONE SODIUM SUCCINATE

Sponsor: BAXTER HLTHCARE

APPLICATION
ANDA086619
TYPE
ANDA
ORIGINAL APPROVAL
1981-05-28
LATEST ACTION
1988-05-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

HYDROCORTISONE SODIUM SUCCINATEDiscontinued
HYDROCORTISONE SODIUM SUCCINATE EQ 100MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

1988-05-05Labeling · Supplement 11AP
1987-01-13Manufacturing (CMC) · Supplement 10AP
1987-01-13Manufacturing (CMC) · Supplement 9AP
1985-12-17Manufacturing (CMC) · Supplement 5AP
1983-02-01Manufacturing (CMC) · Supplement 3AP
1981-05-28OriginalAP
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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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