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FDA NDA · NDA019834

PLENDIL

Sponsor: ASTRAZENECA

APPLICATION
NDA019834
TYPE
NDA
ORIGINAL APPROVAL
1991-07-25
LATEST ACTION
2012-10-31
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

PLENDIL · ReferenceDiscontinued
FELODIPINE 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
PLENDIL · ReferenceDiscontinued
FELODIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
PLENDIL · ReferenceDiscontinued
FELODIPINE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2012-10-31Labeling · Supplement 25 · unknown — Letter ↗AP
2004-06-07Labeling · Supplement 22 · standard — Review ↗AP
2002-09-26Manufacturing (CMC) · Supplement 19 · standard — Review ↗AP
2002-08-26Manufacturing (CMC) · Supplement 20 · standard — Review ↗AP
2002-05-22Labeling · Supplement 17 · standard — Label ↗AP
2000-08-28Labeling · Supplement 15 · standardAP
2000-02-08Labeling · Supplement 14 · standard — Review ↗AP
1999-11-23Manufacturing (CMC) · Supplement 16 · standard — Review ↗AP
1998-07-14Labeling · Supplement 13 · standard — Review ↗AP
1998-01-13Labeling · Supplement 9 · standard — Label ↗AP
1997-10-23Manufacturing (CMC) · Supplement 10 · standardAP
1997-08-07Manufacturing (CMC) · Supplement 12 · standard — Review ↗AP
1996-12-12Manufacturing (CMC) · Supplement 8 · standardAP
1996-07-29Manufacturing (CMC) · Supplement 7 · standard — Review ↗AP
1996-07-03Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
1996-02-05Manufacturing (CMC) · Supplement 5 · standard — Review ↗AP
1995-07-14Labeling · Supplement 4 · standard — Review ↗AP
1994-09-22Efficacy · Supplement 2 · unknown — Review ↗AP
1993-09-22Labeling · Supplement 1 · standardAP
1991-07-25Type 1 - New Molecular Entity · 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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