APPLICATION
BLA017067
TYPE
BLA
ORIGINAL APPROVAL
1973-03-05
LATEST ACTION
2023-10-02
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 20,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 15,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINPrescription
GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL · INJECTABLE · INJECTION
Approval history
2015-09-10Manufacturing (CMC) · Supplement 62 · standardAP
2014-01-29Manufacturing (CMC) · Supplement 60 · standardAP
2013-02-16Manufacturing (CMC) · Supplement 59 · standardAP
2002-11-14Manufacturing (CMC) · Supplement 54 · standardAP
1997-03-06Manufacturing (CMC) · Supplement 52 · standardAP
1993-02-11Labeling · Supplement 51AP
1991-08-15Manufacturing (CMC) · Supplement 50 · standardAP
1991-08-14Manufacturing (CMC) · Supplement 49 · standardAP
1987-08-05Manufacturing (CMC) · Supplement 47 · standardAP
1986-01-10Manufacturing (CMC) · Supplement 46 · standardAP
1984-05-16Manufacturing (CMC) · Supplement 45 · standardAP
1982-10-20Manufacturing (CMC) · Supplement 44 · standardAP
1982-02-03Manufacturing (CMC) · Supplement 43 · standardAP
1981-07-13Efficacy · Supplement 42AP
1980-08-13Efficacy · Supplement 38AP
1980-08-13Efficacy · Supplement 32AP
1980-08-13Efficacy · Supplement 30AP
1980-08-13Efficacy · Supplement 37AP
1980-08-13Efficacy · Supplement 29AP
1980-08-13Efficacy · Supplement 35AP
1980-08-13Efficacy · Supplement 33AP
1980-07-22Labeling · Supplement 2AP
1980-07-22Labeling · Supplement 22AP
1980-07-22Labeling · Supplement 20AP
1980-07-22Labeling · Supplement 10AP
1980-07-22Labeling · Supplement 9AP
1980-07-22Labeling · Supplement 19AP
1980-07-22Labeling · Supplement 11AP
1979-12-18Labeling · Supplement 8AP
1979-12-18Efficacy · Supplement 28AP
1979-12-18Efficacy · Supplement 34AP
1979-12-18Efficacy · Supplement 39AP
1979-12-18Labeling · Supplement 27AP
1979-12-18Efficacy · Supplement 31AP
1979-12-18Labeling · Supplement 15AP
1979-12-18Labeling · Supplement 21AP
1978-03-09Efficacy · Supplement 24AP
1978-03-09Efficacy · Supplement 25AP
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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