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FDA NDA · NDA006882

PHISOHEX

Sponsor: SANOFI AVENTIS US

APPLICATION
NDA006882
TYPE
NDA
ORIGINAL APPROVAL
1949-04-19
LATEST ACTION
2009-07-27
ROUTE
TOPICAL
DOSAGE FORM
EMULSION
MARKETING STATUS
Discontinued

Products

PHISOHEXDiscontinued
HEXACHLOROPHENE 3% · EMULSION · TOPICAL

Approval history

2009-07-27Labeling · Supplement 35 · standardAP
2003-05-27Labeling · Supplement 33 · standardLetterAP
2001-12-19Manufacturing (CMC) · Supplement 32AP
1990-04-03Labeling · Supplement 31AP
1989-12-07Manufacturing (CMC) · Supplement 29AP
1989-07-17Labeling · Supplement 30AP
1988-03-23Manufacturing (CMC) · Supplement 28AP
1984-04-09Labeling · Supplement 26AP
1982-11-05Manufacturing (CMC) · Supplement 27AP
1981-05-15Manufacturing (CMC) · Supplement 25AP
1975-02-21Labeling · Supplement 16AP
1949-04-19UNKNOWN · Original · unknownAP
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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