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FDA NDA · NDA008922

CALCIUM DISODIUM VERSENATE

Sponsor: BAUSCH

APPLICATION
NDA008922
TYPE
NDA
ORIGINAL APPROVAL
1953-07-16
LATEST ACTION
2023-09-29
ROUTE
INJECTION, ORAL
DOSAGE FORM
INJECTABLE, TABLET
MARKETING STATUS
Discontinued

Products

CALCIUM DISODIUM VERSENATE · ReferenceDiscontinued
EDETATE CALCIUM DISODIUM 200MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
CALCIUM DISODIUM VERSENATEDiscontinued
EDETATE CALCIUM DISODIUM 500MG · TABLET · ORAL

Approval history

2023-09-29Labeling · Supplement 22 · standard — Letter ↗AP
2015-06-17Manufacturing (CMC) · Supplement 19 · priorityAP
2013-06-21Manufacturing (CMC) · Supplement 18 · priority — Letter ↗AP
2009-05-19Labeling · Supplement 16 · standard — Letter ↗AP
2002-04-12Manufacturing (CMC) · Supplement 15 · priorityAP
1996-09-26Labeling · Supplement 14 · standardAP
1992-10-05Labeling · Supplement 13 · standardAP
1992-03-03Labeling · Supplement 12AP
1985-04-25Manufacturing (CMC) · Supplement 11 · priorityAP
1953-07-16Type 1 - New Molecular Entity · Original · priorityAP
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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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