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FDA NDA · NDA020792

CARDIZEM

Sponsor: BIOVAIL

APPLICATION
NDA020792
TYPE
NDA
ORIGINAL APPROVAL
1997-09-05
LATEST ACTION
2001-06-04
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

CARDIZEMDiscontinued
DILTIAZEM HYDROCHLORIDE 100MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

2001-06-04Manufacturing (CMC) · Supplement 4 · standardAP
2001-01-26Manufacturing (CMC) · Supplement 3 · standardAP
1997-11-20Manufacturing (CMC) · Supplement 1 · standardAP
1997-09-05Type 3 - New Dosage Form · 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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