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FDA NDA · NDA018342

WELLCOVORIN

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APPLICATION
NDA018342
TYPE
NDA
ORIGINAL APPROVAL
1983-07-08
LATEST ACTION
2026-03-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

WELLCOVORIN · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
WELLCOVORIN · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2026-03-09Efficacy · Supplement 15 · priority — Label ↗AP
1996-06-06Labeling · Supplement 14 · standardAP
1993-04-14Labeling · Supplement 8AP
1983-07-08Type 3 - New Dosage Form · Original · standardAP
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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