APPLICATION
ANDA201046
TYPE
ANDA
ORIGINAL APPROVAL
2013-07-29
LATEST ACTION
2020-08-18
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
2020-08-18Manufacturing (CMC) · Supplement 5 · standardAP
2020-02-25Labeling · Supplement 7 · standardAP
2020-02-25Labeling · Supplement 1 · standardAP
2020-02-25Labeling · Supplement 4 · standardAP
2020-02-25Labeling · Supplement 2 · 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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