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FDA NDA · NDA020458

GALZIN

zinc acetate

Sponsor: ETON

APPLICATION
NDA020458
TYPE
NDA
ORIGINAL APPROVAL
1997-01-28
LATEST ACTION
2024-04-25
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

GALZIN · ReferencePrescription
ZINC ACETATE EQ 25MG ZINC · CAPSULE · ORAL
GALZIN · ReferencePrescription
ZINC ACETATE EQ 50MG ZINC · CAPSULE · ORAL

Approval history

2024-04-25Labeling · Supplement 9 · standard — Letter ↗AP
2016-01-05Manufacturing (CMC) · Supplement 7 · standardAP
2015-05-22Manufacturing (CMC) · Supplement 6 · standardAP
2013-08-01Manufacturing (CMC) · Supplement 5 · standardAP
2002-03-14Labeling · Supplement 2 · standard — Letter ↗AP
1998-05-19Manufacturing (CMC) · Supplement 1 · standardAP
1997-01-28Type 2 - New Active Ingredient · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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