← FDA DRUG APPROVALS

FDA BLA · BLA020898

THYROGEN

thyrotropin alfa

Sponsor: GENZYME

APPLICATION
BLA020898
TYPE
BLA
ORIGINAL APPROVAL
1998-11-30
LATEST ACTION
2020-03-12
ROUTE
INTRAMUSCULAR, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

THYROGENPrescription
THYROTROPIN ALFA 1.1MG/VIAL · INJECTABLE · INJECTION

Approval history

2020-03-12Efficacy · Supplement 65 · standard — Letter ↗AP
2020-03-12Labeling · Supplement 63 · standard — Letter ↗AP
2017-04-24Labeling · Supplement 60 · standard — Label ↗AP
2014-03-21Efficacy · Supplement 54 · standard — Letter ↗AP
2013-06-12Manufacturing (CMC) · Supplement 56 · priorityAP
2013-05-07Manufacturing (CMC) · Supplement 55 · priorityAP
2012-12-14Manufacturing (CMC) · Supplement 53 · priorityAP
2012-07-27Labeling · Supplement 51 · unknown — Label ↗AP
2008-08-12Labeling · Supplement 38 · standard — Letter ↗AP
2007-12-14Efficacy · Supplement 29 · priority — Label ↗AP
2006-01-24Efficacy · Supplement 31 · unknown — Label ↗AP
2004-03-11Labeling · Supplement 21 · standard — Label ↗AP
2002-10-08Manufacturing (CMC) · Supplement 14 · priorityAP
2002-06-25Manufacturing (CMC) · Supplement 13 · priorityAP
2001-10-26Labeling · Supplement 5 · standardAP
2001-09-17Manufacturing (CMC) · Supplement 12 · priorityAP
2001-06-13Manufacturing (CMC) · Supplement 11 · priorityAP
2001-03-15Manufacturing (CMC) · Supplement 10 · priorityAP
2001-03-01Manufacturing (CMC) · Supplement 8 · priorityAP
2001-03-01Manufacturing (CMC) · Supplement 9 · priorityAP
2001-02-28Manufacturing (CMC) · Supplement 7 · priorityAP
2000-05-25Manufacturing (CMC) · Supplement 4 · priorityAP
1999-11-16Manufacturing (CMC) · Supplement 3 · priorityAP
1999-09-03Manufacturing (CMC) · Supplement 1 · priorityAP
1999-09-02Manufacturing (CMC) · Supplement 2 · priorityAP
1998-11-30Type 1 - New Molecular Entity · Original · priority — Other ↗AP
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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