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FDA NDA · NDA020250

HALFAN

Sponsor: GLAXOSMITHKLINE

APPLICATION
NDA020250
TYPE
NDA
ORIGINAL APPROVAL
1992-07-24
LATEST ACTION
2002-08-01
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HALFANDiscontinued
HALOFANTRINE HYDROCHLORIDE 250MG · TABLET · ORAL

Approval history

2002-08-01Labeling · Supplement 8 · standard — Letter ↗AP
2002-08-01Labeling · Supplement 7 · standard — Label ↗AP
1997-08-06Labeling · Supplement 6 · standardAP
1997-08-06Labeling · Supplement 2 · standardAP
1993-09-23Manufacturing (CMC) · Supplement 5 · priorityAP
1993-02-12Labeling · Supplement 3 · standardAP
1992-12-02Manufacturing (CMC) · Supplement 1 · priorityAP
1992-07-24Type 1 - New Molecular Entity · Original · priorityAP
VIEW ON DRUGS@FDA ↗

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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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