APPLICATION
NDA020005
TYPE
NDA
ORIGINAL APPROVAL
1992-02-21
LATEST ACTION
2016-08-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
CARDENE SR · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 60MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
CARDENE SR · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
CARDENE SR · ReferenceDiscontinued
NICARDIPINE HYDROCHLORIDE 45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · CAPSULE, EXTENDED RELEASE · ORAL
Approval history
2002-07-30Manufacturing (CMC) · Supplement 7 · standardAP
2001-11-09Manufacturing (CMC) · Supplement 6 · standardAP
1999-09-29Labeling · Supplement 5 · standardAP
1997-01-07Manufacturing (CMC) · Supplement 4 · standardAP
1996-02-22Manufacturing (CMC) · Supplement 3 · standardAP
1993-11-04Labeling · Supplement 2 · standardAP
1992-11-20Labeling · Supplement 1 · standardAP
1992-02-21Type 3 - New Dosage Form · Original · standardAP
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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