← FDA DRUG APPROVALS

FDA NDA · NDA020372

MYOVIEW

tetrofosmin

Sponsor: MEDI-PHYSICS

APPLICATION
NDA020372
TYPE
NDA
ORIGINAL APPROVAL
1996-02-09
LATEST ACTION
2022-12-06
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MYOVIEW · ReferencePrescription
TECHNETIUM TC-99M TETROFOSMIN KIT N/A · INJECTABLE · INJECTION
MYOVIEW 30ML · ReferencePrescription
TECHNETIUM TC-99M TETROFOSMIN KIT N/A · INJECTABLE · INJECTION

Approval history

2022-12-06Labeling · Supplement 33 · standard — Letter ↗AP
2022-03-09Labeling · Supplement 31 · standard — Letter ↗AP
2017-04-17Labeling · Supplement 28 · standard — Letter ↗AP
2013-03-08Manufacturing (CMC) · Supplement 25 · standardAP
2009-02-26Manufacturing (CMC) · Supplement 22 — Letter ↗AP
2005-07-07Manufacturing (CMC) · Supplement 19 · standard — Label ↗AP
2003-11-13Labeling · Supplement 15 · standard — Letter ↗AP
2003-02-28Efficacy · Supplement 13 · standard — Review ↗AP
2002-11-25Manufacturing (CMC) · Supplement 12 · standardAP
2002-05-22Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP
2001-12-04Manufacturing (CMC) · Supplement 10 · standardAP
2001-11-23Efficacy · Supplement 3 · standard — Letter ↗AP
2001-08-27Manufacturing (CMC) · Supplement 9 · standard — Label ↗AP
2001-04-10Manufacturing (CMC) · Supplement 8 · standardAP
2000-09-29Manufacturing (CMC) · Supplement 7 · standardAP
2000-04-13Manufacturing (CMC) · Supplement 5 · standardAP
2000-04-12Manufacturing (CMC) · Supplement 6 · standardAP
1999-11-12Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-09Manufacturing (CMC) · Supplement 2 · standardAP
1998-12-07Manufacturing (CMC) · Supplement 1 · standardAP
1996-02-09Type 1 - New Molecular Entity · Original · standardAP
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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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