← FDA DRUG APPROVALS

FDA NDA · NDA018959

ZINC

zinc chloride

Sponsor: HOSPIRA

APPLICATION
NDA018959
TYPE
NDA
ORIGINAL APPROVAL
1986-06-26
LATEST ACTION
2024-04-25
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ZINC CHLORIDE IN PLASTIC CONTAINER · ReferencePrescription
ZINC CHLORIDE EQ 1MG ZINC/ML · INJECTABLE · INJECTION

Approval history

2024-04-25Labeling · Supplement 32 · standard — Letter ↗AP
2014-06-12Manufacturing (CMC) · Supplement 22 · priorityAP
2003-02-14Labeling · Supplement 11 · standard — Letter ↗AP
2003-02-14Labeling · Supplement 8 · standard — Letter ↗AP
2001-02-16Manufacturing (CMC) · Supplement 10 · priorityAP
1999-08-31Manufacturing (CMC) · Supplement 9 · priorityAP
1999-01-22Manufacturing (CMC) · Supplement 7 · priorityAP
1997-01-17Manufacturing (CMC) · Supplement 5 · priorityAP
1996-08-29Manufacturing (CMC) · Supplement 6 · priorityAP
1987-06-29Manufacturing (CMC) · Supplement 3 · priorityAP
1986-09-09Manufacturing (CMC) · Supplement 1 · priorityAP
1986-06-26Type 5 - New Formulation or New Manufacturer · 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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