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FDA NDA · NDA020760

TROVAN PRESERVATIVE FREE

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APPLICATION
NDA020760
TYPE
NDA
ORIGINAL APPROVAL
1997-12-18
LATEST ACTION
2000-05-17
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

TROVAN PRESERVATIVE FREEDiscontinued
ALATROFLOXACIN MESYLATE EQ 200MG BASE/VIAL · INJECTABLE · INJECTION
TROVAN PRESERVATIVE FREEDiscontinued
ALATROFLOXACIN MESYLATE EQ 300MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2000-05-17Labeling · Supplement 5 · standardAP
2000-05-17Labeling · Supplement 3 · standardAP
2000-05-17Labeling · Supplement 6 · standardAP
2000-05-17Labeling · Supplement 4 · standardAP
1999-03-02Manufacturing (CMC) · Supplement 2 · standardAP
1998-09-23Labeling · Supplement 1 · standardAP
1997-12-18Type 1 - New Molecular Entity · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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