APPLICATION
NDA008317
TYPE
NDA
ORIGINAL APPROVAL
1952-03-14
LATEST ACTION
2002-11-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ACTHDiscontinued
CORTICOTROPIN 40 UNITS/VIAL · INJECTABLE · INJECTION
ACTHDiscontinued
CORTICOTROPIN 25 UNITS/VIAL · INJECTABLE · INJECTION
Approval history
2002-11-12Labeling · Supplement 11AP
1996-07-25Manufacturing (CMC) · Supplement 16 · standardAP
1990-05-23Labeling · Supplement 15AP
1989-02-23Labeling · Supplement 13AP
1988-01-19Manufacturing (CMC) · Supplement 14 · standardAP
1981-12-01Manufacturing (CMC) · Supplement 12 · standardAP
1980-04-08Labeling · Supplement 9AP
1978-03-30Labeling · Supplement 8AP
1952-03-14Type 5 - New Formulation or New Manufacturer · 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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