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FDA BLA · BLA017836

JEANATOPE

Sponsor: ISO TEX

APPLICATION
BLA017836
TYPE
BLA
ORIGINAL APPROVAL
1976-02-23
LATEST ACTION
2023-07-12
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

JEANATOPEPrescription
ALBUMIN IODINATED I-125 SERUM 500uCi/0.5ML · INJECTABLE · INJECTION
JEANATOPEPrescription
ALBUMIN IODINATED I-125 SERUM 1,000uCi/ML · INJECTABLE · INJECTION
JEANATOPEPrescription
ALBUMIN IODINATED I-125 SERUM 100uCi/10ML (10uCi/ML) · INJECTABLE · INJECTION

Approval history

2023-07-12Labeling · Supplement 9 · standard — Letter ↗AP
2004-06-08Manufacturing (CMC) · Supplement 8 · priority — Letter ↗AP
1996-05-21Manufacturing (CMC) · Supplement 7 · priorityAP
1977-02-03Labeling · Supplement 4AP
1977-02-03Labeling · Supplement 2AP
1977-02-03Labeling · Supplement 3AP
1976-10-08Labeling · Supplement 1AP
1976-02-23Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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