APPLICATION
BLA021149
TYPE
BLA
ORIGINAL APPROVAL
2000-09-20
LATEST ACTION
2015-09-30
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription
Products
OVIDRELDiscontinued
CHORIOGONADOTROPIN ALFA 0.25MG/VIAL · INJECTABLE · INJECTION
OVIDRELPrescription
CHORIOGONADOTROPIN ALFA EQ 0.25MG /0.5ML · INJECTABLE · SUBCUTANEOUS
Approval history
2015-09-30Manufacturing (CMC) · Supplement 40 · standardAP
2014-12-11Manufacturing (CMC) · Supplement 39 · standardAP
2013-12-19Manufacturing (CMC) · Supplement 37 · standardAP
2013-12-11Manufacturing (CMC) · Supplement 36 · standardAP
2013-07-09Manufacturing (CMC) · Supplement 17 · standardAP
2013-04-11Manufacturing (CMC) · Supplement 35 · standardAP
2013-04-05Manufacturing (CMC) · Supplement 34 · standardAP
2013-02-08Manufacturing (CMC) · Supplement 32 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 30 · standardAP
2013-01-31Manufacturing (CMC) · Supplement 33 · standardAP
2013-01-15Manufacturing (CMC) · Supplement 29 · standardAP
2013-01-15Manufacturing (CMC) · Supplement 31 · standardAP
2012-12-13Manufacturing (CMC) · Supplement 25 · standardAP
2012-12-10Manufacturing (CMC) · Supplement 26 · standardAP
2002-05-15Manufacturing (CMC) · Supplement 1 · 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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