APPLICATION
NDA010831
TYPE
NDA
ORIGINAL APPROVAL
1957-09-12
LATEST ACTION
1992-07-14
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
CORTICOTROPINDiscontinued
CORTICOTROPIN 80 UNITS/ML · INJECTABLE · INJECTION
CORTICOTROPINDiscontinued
CORTICOTROPIN 40 UNITS/ML · INJECTABLE · INJECTION
Approval history
1992-07-14Manufacturing (CMC) · Supplement 54 · standardAP
1989-08-30Manufacturing (CMC) · Supplement 53 · standardAP
1988-04-28Labeling · Supplement 52 · standardAP
1985-01-09Labeling · Supplement 51 · standardAP
1980-12-01Efficacy · Supplement 49 · standardAP
1980-12-01Efficacy · Supplement 48 · standardAP
1978-02-17Manufacturing (CMC) · Supplement 40 · standardAP
1977-08-17Labeling · Supplement 43 · standardAP
1977-08-17Labeling · Supplement 42 · standardAP
1977-02-09Labeling · Supplement 39 · standardAP
1976-08-05Manufacturing (CMC) · Supplement 38 · standardAP
1976-06-29Labeling · Supplement 37 · standardAP
1976-06-29Labeling · Supplement 36 · standardAP
1976-05-03Labeling · Supplement 35 · standardAP
1975-12-31Labeling · Supplement 34 · standardAP
1975-12-31Labeling · Supplement 32 · standardAP
1957-09-12Type 3 - New Dosage Form · 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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