APPLICATION
NDA016750
TYPE
NDA
ORIGINAL APPROVAL
1970-04-22
LATEST ACTION
2023-12-22
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
CORTROSYN · ReferencePrescription
COSYNTROPIN 0.25MG/VIAL · INJECTABLE · INJECTION
Approval history
2014-09-29Manufacturing (CMC) · Supplement 28 · standardAP
2000-12-07Manufacturing (CMC) · Supplement 17 · standardAP
1999-03-18Manufacturing (CMC) · Supplement 16 · standardAP
1998-01-09Labeling · Supplement 15 · standardAP
1997-04-08Manufacturing (CMC) · Supplement 13 · standardAP
1997-01-29Manufacturing (CMC) · Supplement 14 · standardAP
1994-02-18Manufacturing (CMC) · Supplement 12 · standardAP
1989-04-28Labeling · Supplement 10AP
1988-10-28Manufacturing (CMC) · Supplement 9 · standardAP
1988-05-09Manufacturing (CMC) · Supplement 8 · standardAP
1987-05-08Manufacturing (CMC) · Supplement 6 · standardAP
1987-02-26Manufacturing (CMC) · Supplement 7 · standardAP
1987-02-10Manufacturing (CMC) · Supplement 5 · standardAP
1986-04-02Labeling · Supplement 4AP
1982-10-26Manufacturing (CMC) · Supplement 3 · standardAP
1982-04-28Manufacturing (CMC) · Supplement 2 · standardAP
1970-04-22Type 1 - New Molecular Entity · 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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.