APPLICATION
BLA017016
TYPE
BLA
ORIGINAL APPROVAL
1974-01-15
LATEST ACTION
2023-05-23
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 2,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINPrescription
GONADOTROPIN, CHORIONIC 10,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 2,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINPrescription
GONADOTROPIN, CHORIONIC 5,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 20,000 UNITS/VIAL · INJECTABLE · INJECTION
CHORIONIC GONADOTROPINDiscontinued
GONADOTROPIN, CHORIONIC 15,000 UNITS/VIAL · INJECTABLE · INJECTION
Approval history
2017-01-09Manufacturing (CMC) · Supplement 163 · standardAP
2016-03-07Manufacturing (CMC) · Supplement 160 · standardAP
2015-10-21Manufacturing (CMC) · Supplement 159 · standardAP
2014-05-02Manufacturing (CMC) · Supplement 158 · standardAP
2008-06-10Manufacturing (CMC) · Supplement 155AP
2002-10-21Labeling · Supplement 150 · standardAP
1999-01-13Manufacturing (CMC) · Supplement 148 · standardAP
1998-08-21Manufacturing (CMC) · Supplement 147 · standardAP
1998-04-15Manufacturing (CMC) · Supplement 146 · standardAP
1997-04-07Manufacturing (CMC) · Supplement 145 · standardAP
1996-11-27Manufacturing (CMC) · Supplement 143 · standardAP
1996-11-18Manufacturing (CMC) · Supplement 144 · standardAP
1994-03-22Manufacturing (CMC) · Supplement 141 · standardAP
1993-05-28Labeling · Supplement 142 · standardAP
1993-02-11Labeling · Supplement 140 · standardAP
1991-09-23Labeling · Supplement 138AP
1991-09-05Manufacturing (CMC) · Supplement 139 · standardAP
1990-02-16Manufacturing (CMC) · Supplement 136 · standardAP
1990-02-06Labeling · Supplement 137AP
1988-12-28Manufacturing (CMC) · Supplement 135 · standardAP
1988-01-05Labeling · Supplement 134AP
1986-05-12Manufacturing (CMC) · Supplement 133 · standardAP
1985-02-15Manufacturing (CMC) · Supplement 131 · standardAP
1984-12-27Manufacturing (CMC) · Supplement 132 · standardAP
1984-09-18Manufacturing (CMC) · Supplement 130 · standardAP
1982-10-20Labeling · Supplement 126AP
1982-06-10Labeling · Supplement 127AP
1981-06-24Manufacturing (CMC) · Supplement 121 · standardAP
1981-04-15Manufacturing (CMC) · Supplement 123 · standardAP
1981-01-05Labeling · Supplement 113AP
1981-01-05Labeling · Supplement 116AP
1980-11-07Manufacturing (CMC) · Supplement 108 · standardAP
1980-03-11Labeling · Supplement 107AP
1980-03-11Labeling · Supplement 105AP
1980-03-11Labeling · Supplement 103AP
1980-03-11Labeling · Supplement 101AP
1980-03-11Labeling · Supplement 106AP
1980-03-11Labeling · Supplement 104AP
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.