APPLICATION
ANDA079051
TYPE
ANDA
ORIGINAL APPROVAL
2008-07-25
LATEST ACTION
2022-08-11
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
NISOLDIPINEDiscontinued
NISOLDIPINE 40MG · TABLET, EXTENDED RELEASE · ORAL
NISOLDIPINEDiscontinued
NISOLDIPINE 20MG · TABLET, EXTENDED RELEASE · ORAL
NISOLDIPINEDiscontinued
NISOLDIPINE 30MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2022-08-11Labeling · Supplement 5 · 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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