← FDA DRUG APPROVALS

FDA NDA · NDA017412

GERMA-MEDICA

Sponsor: HUNTINGTON LABS

APPLICATION
NDA017412
TYPE
NDA
ORIGINAL APPROVAL
1978-02-03
LATEST ACTION
1980-04-24
ROUTE
TOPICAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

GERMA-MEDICADiscontinued
HEXACHLOROPHENE 1% · SOLUTION · TOPICAL
GERMA-MEDICA "MG"Discontinued
HEXACHLOROPHENE 0.25% · SOLUTION · TOPICAL

Approval history

1980-04-24Labeling · Supplement 4 · standardAP
1980-04-24Manufacturing (CMC) · Supplement 3 · standardAP
1978-04-14Labeling · Supplement 1 · standardAP
1978-02-03Type 5 - New Formulation or New Manufacturer · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →