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FDA ANDA · ANDA208862

RANOLAZINE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA208862
TYPE
ANDA
ORIGINAL APPROVAL
2019-05-28
LATEST ACTION
2020-03-15
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

2020-03-15Labeling · Supplement 3 · standardAP
2019-05-28UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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