← FDA DRUG APPROVALS

FDA NDA · NDA018035

TECHNETIUM TC 99M MEDRONATE

Sponsor: JUBILANT

APPLICATION
NDA018035
TYPE
NDA
ORIGINAL APPROVAL
1978-11-28
LATEST ACTION
2025-05-22
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued, Prescription

Products

DRAXIMAGE MDP-10Discontinued
TECHNETIUM TC-99M MEDRONATE N/A · INJECTABLE · INJECTION
DRAXIMAGE MDP-25 · ReferencePrescription
TECHNETIUM TC-99M MEDRONATE N/A · INJECTABLE · INJECTION

Approval history

2025-05-22Labeling · Supplement 43 · standard — Letter ↗AP
2011-09-23Labeling · Supplement 32 · standard — Label ↗AP
2010-10-22Labeling · Supplement 29 · unknown — Letter ↗AP
2009-07-08Manufacturing (CMC) · Supplement 24 · standard — Letter ↗AP
2004-02-27Manufacturing (CMC) · Supplement 18 · standard — Letter ↗AP
2002-07-03Manufacturing (CMC) · Supplement 17 · standard — Letter ↗AP
1999-04-02Labeling · Supplement 16 · standardAP
1999-04-02Labeling · Supplement 15 · standardAP
1996-08-23Labeling · Supplement 14 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 13 · standardAP
1988-12-08Manufacturing (CMC) · Supplement 8 · standardAP
1988-10-31Labeling · Supplement 12AP
1980-05-30Labeling · Supplement 1AP
1980-05-29Manufacturing (CMC) · Supplement 2 · standardAP
1979-10-15Labeling · Supplement 4AP
1979-04-26Manufacturing (CMC) · Supplement 3 · standardAP
1978-11-28Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗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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