FDA NDA · NDA018511

DRAXIMAGE DTPA

kit for the preparation of technetium tc 99m pentetate

Sponsor: JUBILANT

APPLICATION

NDA018511

TYPE

NDA

ORIGINAL APPROVAL

1989-12-29

LATEST ACTION

2023-06-07

ROUTE

INTRAVENOUS, RESPIRATORY (INHALATION), INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription

Products

DRAXIMAGE DTPA · ReferencePrescription

TECHNETIUM TC-99M PENTETATE KIT N/A · INJECTABLE · INJECTION

2023-06-07Labeling · Supplement 32 · standard — Letter ↗AP

2022-10-12Manufacturing (CMC) · Supplement 31 — Letter ↗AP

2017-12-26Efficacy · Supplement 28 · standard — Label ↗AP

2017-12-22Manufacturing (CMC) · Supplement 20 · standard — Label ↗AP

2015-01-05Manufacturing (CMC) · Supplement 26 · standardAP

2014-10-27Manufacturing (CMC) · Supplement 25 · standardAP

2014-03-28Manufacturing (CMC) · Supplement 24 · standardAP

2011-09-23Labeling · Supplement 19 · standard — Letter ↗AP

2001-12-10Manufacturing (CMC) · Supplement 7 · standardAP

1999-04-02Labeling · Supplement 5 · standardAP

1999-04-02Labeling · Supplement 6 · standardAP

1996-08-23Labeling · Supplement 4 · standardAP

1994-08-09Manufacturing (CMC) · Supplement 3 · standardAP

1994-03-30Manufacturing (CMC) · Supplement 2 · standardAP

1990-09-07Labeling · Supplement 1AP

1989-12-29Type 5 - New Formulation or New Manufacturer · Original · 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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