APPLICATION
NDA020356
TYPE
NDA
ORIGINAL APPROVAL
1995-02-02
LATEST ACTION
2017-06-13
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued, Prescription
Products
SULAR · ReferenceDiscontinued
NISOLDIPINE 25.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 17MG · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 34MG · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferenceDiscontinued
NISOLDIPINE 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
SULAR · ReferencePrescription
NISOLDIPINE 8.5MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2016-05-20Manufacturing (CMC) · Supplement 26 · standardAP
2002-10-11Manufacturing (CMC) · Supplement 14 · standardAP
2002-08-13Manufacturing (CMC) · Supplement 13 · standardAP
2001-03-14Manufacturing (CMC) · Supplement 12 · standardAP
2000-09-26Labeling · Supplement 11 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 10 · standardAP
1998-12-16Labeling · Supplement 9 · standardAP
1997-02-19Labeling · Supplement 5 · standardAP
1997-01-24Manufacturing (CMC) · Supplement 6 · standardAP
1996-10-23Labeling · Supplement 4 · standardAP
1996-01-05Manufacturing (CMC) · Supplement 3 · standardAP
1995-12-05Labeling · Supplement 2 · standardAP
1995-07-26Manufacturing (CMC) · Supplement 1 · 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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