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FDA NDA · NDA012402

IVADANTIN

Sponsor: PROCTER AND GAMBLE

APPLICATION
NDA012402
TYPE
NDA
ORIGINAL APPROVAL
1960-09-15
LATEST ACTION
1982-10-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

IVADANTINDiscontinued
NITROFURANTOIN SODIUM EQ 180MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

1982-10-18Labeling · Supplement 19 · standardAP
1982-04-13Manufacturing (CMC) · Supplement 21 · standardAP
1979-07-13Labeling · Supplement 17 · standardAP
1979-06-06Manufacturing (CMC) · Supplement 15 · standardAP
1979-06-06Labeling · Supplement 16 · standardAP
1960-09-15Type 2 - New Active Ingredient · 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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