APPLICATION
ANDA211291
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-28
LATEST ACTION
2020-01-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
RANOLAZINEDiscontinued
RANOLAZINE 1GM · TABLET, EXTENDED RELEASE · ORAL
RANOLAZINEDiscontinued
RANOLAZINE 500MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2020-01-22Labeling · Supplement 2 · standardAP
2019-10-31Labeling · Supplement 1 · standardAP
2019-05-28UNKNOWN · 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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