← FDA DRUG APPROVALS

FDA NDA · NDA019488

CARDENE

Sponsor: CHIESI

APPLICATION
NDA019488
TYPE
NDA
ORIGINAL APPROVAL
1988-12-21
LATEST ACTION
2016-08-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

CARDENE · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL
CARDENE · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE · ORAL

Approval history

2016-08-26Labeling · Supplement 10 · standard — Letter ↗AP
2001-11-09Manufacturing (CMC) · Supplement 9 · standardAP
1999-09-20Labeling · Supplement 8 · standardAP
1994-12-30Manufacturing (CMC) · Supplement 7 · standardAP
1992-12-17Manufacturing (CMC) · Supplement 6 · standardAP
1990-10-16Manufacturing (CMC) · Supplement 5 · standardAP
1990-06-07Manufacturing (CMC) · Supplement 4 · standardAP
1989-09-12Manufacturing (CMC) · Supplement 3 · standardAP
1989-09-12Manufacturing (CMC) · Supplement 2 · standardAP
1989-04-18Manufacturing (CMC) · Supplement 1 · standardAP
1988-12-21Type 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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