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FDA ANDA · ANDA212889

RANOLAZINE

Sponsor: RISING

APPLICATION
ANDA212889
TYPE
ANDA
ORIGINAL APPROVAL
2021-01-28
LATEST ACTION
2022-07-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

RANOLAZINEPrescription
RANOLAZINE 500MG · TABLET, EXTENDED RELEASE · ORAL
RANOLAZINEPrescription
RANOLAZINE 1GM · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-07-01Manufacturing (CMC) · Supplement 2 · unknownAP
2021-01-28UNKNOWN · 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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