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FDA NDA · NDA020668

LEXXEL

Sponsor: ASTRAZENECA

APPLICATION
NDA020668
TYPE
NDA
ORIGINAL APPROVAL
1996-12-27
LATEST ACTION
2007-10-04
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

LEXXELDiscontinued
ENALAPRIL MALEATE 5MG, FELODIPINE 5MG · TABLET, EXTENDED RELEASE · ORAL
LEXXELDiscontinued
ENALAPRIL MALEATE 5MG, FELODIPINE 2.5MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2007-10-04Labeling · Supplement 13 · standard — Letter ↗AP
2005-08-02Labeling · Supplement 5 · standard — Label ↗AP
2004-12-23Labeling · Supplement 12 · standard — Letter ↗AP
2004-06-07Labeling · Supplement 11 · standard — Label ↗AP
2003-06-11Labeling · Supplement 9 · standard — Letter ↗AP
2001-09-18Labeling · Supplement 8 · standardAP
2001-02-06Manufacturing (CMC) · Supplement 7 · standardAP
2000-07-18Labeling · Supplement 6 · standardAP
1998-10-28Manufacturing (CMC) · Supplement 3 · standard — Review ↗AP
1998-07-22Labeling · Supplement 4 · standard — Review ↗AP
1998-03-03Labeling · Supplement 2 · standard — Review ↗AP
1997-07-02Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1996-12-27Type 4 - New Combination · 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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