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FDA NDA · NDA020707

SKELID

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APPLICATION
NDA020707
TYPE
NDA
ORIGINAL APPROVAL
1997-03-07
LATEST ACTION
2010-03-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

SKELID · ReferenceDiscontinued
TILUDRONATE DISODIUM EQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2010-03-19Labeling · Supplement 6 · standard — Letter ↗AP
2006-11-17Labeling · Supplement 5 · standard — Label ↗AP
2003-08-21Labeling · Supplement 4 · standard — Letter ↗AP
1998-06-03Manufacturing (CMC) · Supplement 1 · standardAP
1997-03-07Type 1 - New Molecular Entity · 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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