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FDA NDA · NDA007504

ACTHAR

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA007504
TYPE
NDA
ORIGINAL APPROVAL
1950-07-03
LATEST ACTION
1992-04-20
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ACTHARDiscontinued
CORTICOTROPIN 25 UNITS/VIAL · INJECTABLE · INJECTION
ACTHARDiscontinued
CORTICOTROPIN 40 UNITS/VIAL · INJECTABLE · INJECTION

Approval history

1992-04-20Labeling · Supplement 20 · priorityAP
1983-08-24Labeling · Supplement 19 · priorityAP
1981-03-26Labeling · Supplement 18 · priorityAP
1979-06-26Labeling · Supplement 15 · priorityAP
1979-06-26Labeling · Supplement 16 · priorityAP
1977-10-05Labeling · Supplement 14 · priorityAP
1977-05-25Labeling · Supplement 13 · priorityAP
1975-12-30Labeling · Supplement 10 · priorityAP
1975-10-03Labeling · Supplement 9 · priorityAP
1950-07-03Type 1 - New Molecular Entity · Original · priorityAP
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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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