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FDA NDA · NDA020507

TECZEM

Sponsor: BIOVAIL

APPLICATION
NDA020507
TYPE
NDA
ORIGINAL APPROVAL
1996-10-04
LATEST ACTION
2002-02-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

TECZEMDiscontinued
DILTIAZEM MALATE EQ 180MG HYDROCHLORIDE, ENALAPRIL MALEATE 5MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2002-02-04Manufacturing (CMC) · Supplement 3 · standardAP
2000-03-03Labeling · Supplement 2 · standardAP
1999-02-17Labeling · Supplement 1 · standard — Review ↗AP
1996-10-04Type 2 New Active Ingredient and Type 4 New Combination · Original · standardAP
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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